UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K/A
(AMENDMENT No. 1)
FOR ANNUAL AND TRANSITIONAL REPORTS
PURSUANT TO SECTIONS 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 1997
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission File Number 0-19635
GENTA INCORPORATED
(Exact name of Registrant as specified
in its certificate of incorporation)
Delaware 33-0326866
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
3550 General Atomics Court
San Diego, California 92121
(Address of principal executive offices) (Zip Code)
(619) 455-2700
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to
Section 12(g) of the Act: Common Stock, $.001 par value
Preferred Stock Purchase Rights,
Par Value $.001
(Title of Class)
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Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes [X] No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K/A or any amendment to
this Form 10-K/A. [ ]
The approximate aggregate market value of the voting common equity held by
non-affiliates of the registrant was approximately 6.0 million as of April 2,
1998. For purposes of determining this number, 136,202 shares of common stock
held by affiliates are excluded.
As of April 2, 1998, the registrant had 5,737,756 shares of Common Stock
outstanding.
Documents Incorporated by Reference
Designated portions of Registrant's Definitive Proxy Statement to be furnished
for the Annual Meeting of the Stockholders are incorporated by reference in Part
III of this Form 10-K/A.
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UNLESS OTHERWISE INDICATED, ALL SHARE AND PER SHARE DATA IN THIS REPORT
HAVE BEEN ADJUSTED RETROACTIVELY TO REFLECT A 1-FOR-10 REVERSE STOCK SPLIT OF
THE COMPANY'S COMMON STOCK EFFECTIVE AS OF APRIL 7, 1997.
The statements contained in this Annual Report on Form 10-K/A that are not
historical are forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, including statements regarding the
expectations, beliefs, intentions or strategies regarding the future. The
Company intends that all forward-looking statements be subject to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect the Company's views as of the date they are
made with respect to future events and financial performance, but are subject to
many risks and uncertainties, which could cause the actual results of the
Company to differ materially from any future results expressed or implied by
such forward-looking statements. Examples of such risks and uncertainties
include, but are not limited to: the obtaining of sufficient financing to
maintain the Company's planned operations; the timely development, receipt of
necessary regulatory approvals and acceptance of new products; the successful
application of the Company's technology to produce new products; the obtaining
of proprietary protection for any such technology and products; the impact of
competitive products and pricing and reimbursement policies; the changing of
market conditions and the other risks detailed in the Certain Trends and
Uncertainties section of Management's Discussion and Analysis of Financial
Condition and Results of Operations ("MD&A") in this Annual Report on Form
10-K/A and elsewhere herein. The Company does not undertake to update any
forward-looking statements.
See "MD&A--Certain Trends and Uncertainties" for a discussion of
certain risks and uncertainties applicable to the Company and its stockholders,
including the Company's need for additional funds to sustain its operations.
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PART I
ITEM 1. BUSINESS
OVERVIEW
Genta Incorporated ("Genta" or the "Company"), incorporated under the
laws of the State of Delaware on February 4, 1988, is an emerging
biopharmaceutical company engaged in the development of a pipeline of
pharmaceutical products. Genta's multi-faceted approach has incorporated a
product development portfolio with balanced technical risk, a novel drug
delivery technology and a United States business base. The Company's research
efforts have been focused on the development of proprietary oligonucleotide
pharmaceuticals intended to block or regulate the production of disease-related
proteins at the genetic level. The Company's oligonucleotide programs are
focused primarily in the area of cancer. In late 1995, a phase I/IIa clinical
trial was initiated in the United Kingdom using Genta's anti-bcl-2 Anticode(TM)
oligonucleotide, G3139, in non-Hodgkin's lymphoma patients for whom prior
therapies have failed. The clinical trial is being conducted in collaboration
with the Royal Marsden NHS Trust and the Institute for Cancer Research. In late
1996, an Investigational New Drug application ("IND") for the G3139 clinical
program was filed in the United States and allowed to proceed by the United
States Food and Drug Administration ("FDA"). In late 1997, a phase I trial was
initiated in the United States at the Memorial Sloan-Kettering Cancer Center
(the "MSKCC") in New York City using G3139 in patients diagnosed with various
types of cancer to be followed by a phase IIa trial in prostate cancer. In
addition, the Company owns 50% of a drug delivery system joint venture with
Jagotec AG ("Jagotec"), Genta Jago Technologies B.V. ("Genta Jago") established
to develop oral controlled-release drugs. To date, no products from this joint
venture have been commercialized. The joint venture's original plan was to use
Jagotec's patented GEOMATRIX(R) drug delivery technology ("GEOMATRIX") in a
two-pronged commercialization strategy: the development of generic versions of
successful brand-name controlled-release drugs; and the development of
controlled-release formulations of drugs currently marketed in only
immediate-release form. The only products in development to date are those
intended to be comparable to the commercially available, brand-name,
controlled-release drugs. The Company also manufactures and markets specialty
biochemicals and intermediate products to the in vitro diagnostic and
pharmaceutical industries through its manufacturing subsidiary, JBL Scientific,
Inc. ("JBL"), a California corporation acquired by the Company in February,
1991.
SUMMARY OF BUSINESS AND RESEARCH AND DEVELOPMENT PROGRAMS
The following table describes the major areas to which the Company is
currently directing its research and product development efforts and the
development
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status of products or product candidates under development, as well as other
aspects of the Company's business:
<TABLE>
<CAPTION>
Program Therapeutic Indications Development Status
------- ----------------------- ------------------
<S> <C> <C>
1. Anticode
G3139 o Impairs production of key cancer protein, Phase I/IIa clinical trials in
BCL2 (non-Hodgkin's lymphoma, the United Kingdom with respect
prostate, melanoma, breast and possibly to non-Hodgkin's lymphoma and in
others) the U.S. with respect to
prostate and possibly other
advanced solid tumor
malignancies.
Anti-FAK Oligonucleotides o Impairs production of key cancer protein, Pre-clinical
Focal Adhesion Kinase (melanoma,
lymphoma and multiple myeloma)
2. Oral Controlled-Release
Drugs
Bioequivalent Generics o Various Abbreviated New Drug
Applications ("ANDAs") may be
filed for up to three products
in 1998
3. Biochemical Manufacturing
Specialty Biochemicals; $4.7 million in 1997 sales
Intermediate
Products for biotechnology and
pharmaceutical industries
</TABLE>
ANTICODE(TM) BRAND OF ANTISENSE OLIGONUCLEOTIDE PROGRAMS
Oligonucleotides represent a modern approach to drug development based
upon genetic control of disease. Many human diseases have genetic origins that
involve either the expression of a harmful foreign gene or the aberrant
expression of a normal or mutated human gene. The Company's Anticode(TM)
oligonucleotides are short strands of synthetic nucleic acids designed to bind
to ("hybridize" with) specific sequences of disease-related RNA or DNA, thereby
blocking or controlling production of disease-related proteins. The Company
believes that, because of their selective binding properties, Anticode(TM)
oligonucleotides should not interfere with the function of normal cells, and
therefore, should elicit significantly fewer side effects than traditional
drugs. Oligonucleotide drugs may attack a disease at one of two levels. One
approach is to prevent the synthesis of essential disease-related proteins. In
this approach, certain oligonucleotides are used to interrupt the processing of,
or selectively to bind to and
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destroy, individual messenger RNA (mRNA) sequences, which leads to the
down-regulation (lowering of levels) of specific proteins and thereby
effectively eliminates the disease. This is referred to as the "antisense"
mechanism of action. A second therapeutic opportunity is to prevent
transcription of disease-causing DNA into the mRNA copy of the gene. This is
referred to as the "triple-strand to DNA" mechanism of activity.
Genta has focused its Anticode(TM) research on oligonucleotides with
phosphorothioate backbones and mixed phosphorothioate and methylphosphonate
back- bones. The Company has licensed patents covering phosphorothioate
oligonucleotide constructions and has applied for patents covering the mixed
backbone constructions. Genta's scientists have improved the backbone
technologies by introducing mixed chirally-enriched or chirally-pure
oligonucleotides. In preclinical studies, these oligonucleotides effectively
interfere with the action of targeted mRNA sequences inside cells. Intravenous
administration of the improved technology oligonucleotides to certain animals
demonstrates that these compounds have greater stability in the circulatory
system and are eventually excreted intact in the urine. These improved backbone
technologies represent opportunities for second generation Anticode(TM)
antisense oligonucleotides, none of which are currently in development.
Management believes that the Company has the ability to acquire or produce
quantities of oligonucleotides sufficient to support its present needs for
research and its projected needs for initial clinical development programs.
However, in order to obtain oligonucleotides sufficient to meet the volume and
cost requirements needed for certain commercial applications of Anticode(TM)
oligonucleotide products, Genta requires raw materials currently provided by a
single supplier, and there can be no assurance that such supplier will continue
satisfactorily to provide the requisite raw materials. See "MD&A--Certain Trends
and Uncertainties--Difficult Manufacturing Process; Access to Certain Raw
Materials."
The Company's oligonucleotide research and development efforts are
currently focused on its cancer program as described below. Extensive additional
development will be required, and there can be no assurance that any product
will be successfully developed or will receive the necessary regulatory
approvals. See "MD&A--Certain Trends and Uncertainties--No Assurance of
Regulatory Approval; Government Regulation," "MD&A--Certain Trends and
Uncertainties--Dependence on Others" and "MD&A--Certain Trends and
Uncertainties--Uncertainty of Clinical Trials and Results."
Bcl-2 Gene Target.
The bcl-2 gene is a proto-oncogene and a major inhibitor of apoptosis
(programmed cell death) of cancerous cells. The protein produced by this gene
has two known critical functions in the progression of cancer: it makes cancer
cells immortal, creating a survival advantage of malignant over normal cells;
and confers resistance to radiation and chemotherapy, rendering those treatments
ineffective in the late stages of
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many types of cancer. Genta's lead anti-bcl-2 molecule, G3139, is designed to
bind to and destroy the mRNA that produces the bcl-2 protein product, thereby
interfering with the cellular production of the protein. High levels of bcl-2
are associated with a poor clinical prognosis in many solid tumor and
hematological malignancies such as lymphoma, leukemia, melanoma, multiple
myeloma prostate and breast cancers. The Company believes that its Anticode(TM)
antisense strategy against the bcl-2 gene has the potential to represent a
significant therapeutic opportunity in many of these cancers.
In preclinical studies conducted by Dr. Finbarr Cotter, at the
Institute for Child Health in London, an anti-bcl-2 oligonucleotide was shown to
cure lymphoma-like disease induced by the injection of human B-cell lymphoma
cells in immunodeficient mice. In addition, in a variety of other animal
studies, anti-bcl-2 Anticode(TM) oligonucleotides have been found to inhibit the
growth of human lymphoma, melanoma, colon, prostate and breast cancer tumors in
immunodeficient mice when administered alone or in combination with
chemotherapeutic agents. In the February 1998 issue of Nature Medicine, Dr.
Burkhard Jansen and colleagues published a report entitled,"bcl-2 antisense
therapy chemosensitizes human melanoma in SCID mice." They describe studies
showing that G3139 administered with dacarbazine (DTIC) produced significantly
greater tumor volume reduction than dacarbazine alone or than G3139 alone. In
ten of thirteen animals there was no tumor after the combination treatment.
In late 1995, a Phase I/IIa clinical trial was initiated in the United
Kingdom using Genta's anti-bcl-2 Anticode(TM) oligonucleotide, G3139, in human
non-Hodgkin's lymphoma patients for whom prior therapies had failed. The
clinical trial was conducted in collaboration with the Royal Marsden NHS Trust
("Royal Marsden") and the Institute for Cancer Research under the direction of
Dr. David Cunningham. The principal aim of this Phase I/IIa study was to define
the maximum tolerated dose of G3139. Secondary objectives included measurement
of clinical and biochemical disease parameters. The trial with Royal Marsden is
almost complete, and the Company believes that, other than mild irritation at
the site of the subcutaneous infusion in most of the patients or a low- grade
reversible thrombocytopenia (decrease in number of blood platelets), no serious
drug- attributable or dose-limiting adverse effects were seen until the maximum
tolerated dose was reached. Initial results in the first nine patients were
reported in The Lancet ("BCL-2 antisense therapy in patients with non-Hodgkin
lymphoma," A. Webb, et al., Vol. 349; pages 1137-1141, April 19, 1997). This
report revealed that four of the nine patients observed showed improvements in
their disease and in one patient the tumor had completely disappeared. Of the 17
patients treated to date, three suffered what were considered to be drug related
serious adverse events at high levels of drug presentation above the predicted
efficacy range. These events included a grade III skin reaction due to the
subcutaneous method of administration in the study; hypotension, and
thrombocytopenia. These patients were removed from the study and recovered from
the reaction. The patient who had experienced hypotension was later rechallenged
at a lower dose without any untoward event.
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In December 1996, the FDA granted the Company an allowance to initiate
clinical trials under an IND for the use of G3139 against non-Hodgkin's
lymphoma. In 1997, the Company expanded the IND to include the use of G3139
against prostate cancer. In addition, the Company anticipates that it may expand
this IND to include the use of G3139 against other types of cancers, including
melanoma and breast. The Company has had discussions with several cancer centers
regarding additional Phase I/IIa clinical trials of G3139. The Company is
currently discussing protocols with such centers and believes that additional
clinical trials could be commenced in 1998. In addition, the Company has had
discussions with the National Cancer Institute ("NCI") regarding additional
Phase I and II clinical trials. Assuming the Company and NCI agree to move
forward with such NCI sponsored trials, the Company will collaborate with NCI on
the design of such clinical studies and the selection of tumor targets. Under
the proposed arrangement, NCI would cover the costs of running both pre-clinical
and clinical studies while Genta would be responsible for supplying NCI with
necessary quantities of G3139 to carry out this work. There can be no assurance
that such IND for G3139 will be further expanded or that any additional clinical
studies will be conducted. See "MD&A--Certain Trends and Uncertainties--No
Assurance of Regulatory Approval; Government Regulation," "MD&A--Certain Trends
and Uncertainties-- Dependence on Others" and "Risk Factors--Uncertainty of
Clinical Trials and Results."
In December 1997, the Company initiated a United States Phase I/IIa
clinical trial at the MSKCC to evaluate G3139. The first part of the Phase I/IIa
study at the MSKCC is designed to define the maximum tolerated dose or optimal
biological dose with continuous intravenous infusion; the second part is to
determine the efficacy of the drug in advanced, androgen-independent prostate
cancer. Three of the first group of three patients in the dose escalation safety
phase have started treatment at a low dose of drug. The first two patients
completed the study without difficulty during the administration of G3139 and
the third is nearing completion. The first patient suffered a seizure after
treatment was completed, but the event was not considered to be drug related.
On March 31, 1998, the United States Patent and Trademark Office issued
a patent to which the Company has an exclusive license, for claims covering
antisense oligonucleotide compounds targeted against bcl-2. These claims cover
the Company's proprietary Anticode(TM) oligonucleotide molecules that target
bcl-2, including its lead clinical candidate, G3139. Other related patents and
claims in the United States and corresponding foreign patent applications are
still pending. See "MD&A--Certain Trends and Uncertainties--Uncertainty
Regarding Patents and Proprietary Technology."
Focal Adhesion Kinase (FAK) Gene Target.
FAK protein is highly active in the regulation of adhesion dependent
growth and motility of cells. In a variety of cancers such as those implicated
in melanoma, lymphoma and multiple myeloma, the increase of FAK protein has been
detected.
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Moreover, increased synthesis of FAK protein correlates with increased
invasiveness and ability of cancer to spread through the body (metastasize). In
collaborative preclinical experiments with Dr. William G. Cance at the
University of North Carolina, Genta's Anticode(TM) oligonucleotides against FAK
were shown to inhibit the growth of a primary tumor (the site at which the
cancer is believed to have begun) and virtually to eliminate metastases in human
melanoma, immunocompromised mice, xenograft models. Combined with the
observation that anti-FAK oligonucleotides appear to show few adverse effects
against normal tissues, such results indicate that the FAK target may represent
a promising therapeutic opportunity for both the treatment of primary disease
and the prevention of metastatic disease. At the current time the Company's
development work related to FAK-antisense has been placed on hold pending
discussions with Dr. Cance and the University of North Carolina.
Oligonucleotide Collaborative and Licensing Agreements.
Gen-Probe (Chugai). In February 1989, Genta entered into a development,
license and supply agreement with Gen-Probe Incorporated ("Gen-Probe").
Gen-Probe was subsequently acquired by Chugai Pharmaceutical Company, Ltd.
("Chugai"), a Japanese corporation. Gen-Probe has the option to acquire an
exclusive worldwide license to any product consisting of, including, derived
from or based on oligonucleotides for the treatment or prevention of
Epstein-Barr virus, cytomegalovirus, HIV, human T-cell leukemia virus-1 and all
leukemias and lymphomas. Genta is obligated to pursue the development of a
therapeutic compound for the treatment of one of these indications as its first
therapeutic development program. Under the agreement, if Gen-Probe exercises its
option to acquire rights to a product in any such indication, the Company will
grant Gen-Probe certain rights to sell such product and Gen-Probe must fund
Genta's development of any such product, subject to certain limitations and
early termination rights. If Gen-Probe fully funds the development of any such
product, profits on sales of such product will be shared between the parties. In
February 1996, Gen-Probe elected not to exercise such option with respect to
Genta's anti-bcl-2 products, waiving any rights it may have had to develop or
commercialize such products. The Gen-Probe agreement provides for perpetual
worldwide licenses in applicable proprietary rights; royalty payments shall not
accrue beyond the later of fifteen years after the first commercial sale of each
product and the duration of patent in the country of sale. Gen-Probe is a
stockholder in the Company.
Ts'o/Miller/Hopkins. In February 1989, the Company entered into a
license agreement with Drs. Paul Ts'o and Paul Miller (the "Ts'o/Miller
Agreement") pursuant to which Drs. Ts'o and Miller (the "Ts'o/Miller
Partnership") granted an exclusive license to the Company to certain issued
patents, patent applications and related technology regarding the use of nucleic
acids and oligonucleotides including methylphosphonates as pharmaceutical
agents. Dr. Ts'o is a Professor of Biophysics, Department of Biochemistry, and
Dr. Miller is a Professor of Biochemistry, both at the
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School of Public Health and Hygiene, Johns Hopkins University ("Johns Hopkins").
In May 1990, the Company entered into a license agreement with Johns Hopkins
(the "Johns Hopkins Agreement," and collectively with the Ts'o/Miller Agreement,
referred to herein as the "Ts'o/Miller/Hopkins Agreements") pursuant to which
Johns Hopkins granted Genta an exclusive license to its rights in certain issued
patents, patent applications and related technology developed as a result of
research conducted at Johns Hopkins by Drs. Ts'o and Miller and related to the
use of nucleic acids and oligonucleotides as pharmaceutical agents. In addition,
Johns Hopkins granted Genta certain rights of first negotiation to inventions
made by Drs. Ts'o and Miller in their laboratories in the area of
oligonucleotides and to inventions made by investigators at Johns Hopkins in the
course of research funded by Genta, which inventions are not otherwise included
in the Ts'o/Miller/Hopkins Agreements. Genta had agreed to pay Dr. Ts'o, Dr.
Miller and Johns Hopkins royalties on net sales of products covered by the
issued patents and patent applications, but not the related technology, licensed
to the Company under the Ts'o/Miller/Hopkins Agreements. The Company also agreed
to pay certain minimum royalties prior to commencement of commercial sales of
such products, which royalties may be credited under certain conditions against
royalties payable on subsequent sales. Subject to certain rights of early
termination, the Ts'o/Miller/Hopkins Agreements remain in effect for the life of
the last-to-expire patent licensed under the respective agreements or until
abandonment of the last-pending patent application licensed under the respective
agreements.
On February 14, 1997, the Company received notice from Johns Hopkins
that the Company was in material breach of the Johns Hopkins Agreement. The
Johns Hopkins Agreement provides that, if a material payment default is not
cured within 90 days of receipt of notice of such breach, Johns Hopkins may
terminate the Johns Hopkins Agreement. In February 1997, the Company paid Johns
Hopkins $100,000 towards the post-doctoral support program. On May 15, 1997,
Johns Hopkins sent a letter to the Company stating that the Johns Hopkins
Agreement was terminated. According to Johns Hopkins, as of December 31, 1997,
the Company owed Johns Hopkins and the Ts'o/Miller Partnership $602,657.52, of
which $287,500 consisted of royalty payments to the Partnership for 1995 through
1997 and the balance consisted of the Company's obligations to provide funds to
support a post-doctoral research program of Johns Hopkins and to support patent
prosecutions. The Company is in negotiations with Johns Hopkins as to payment of
the remaining balance although there can be no certainty that such negotiations
will be successful. The Company also received notice from the Ts'o/Miller
Partnership that it was in material breach of the license agreement for failure
to pay royalties for 1995 through 1997, which the Ts'o/Miller Partnership
claimed was in the aggregate amount of $275,068.49. This notice also provided
that if such breach was not cured within 90 days, the license would be
terminated. The negotiations that have been undertaken with Johns Hopkins have
included the Ts'o/Miller Partnership as well. Based on a review of the research
conducted with the technology provided by these licenses, the Company concluded
that it could not develop potential products using this
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technology. Management's current strategy, therefore, is to employ alternative
technologies that are available to it through other licenses or its own
intellectual property. Accordingly, the Company no longer believes that the
termination of the Ts'o/Miller/Hopkins Agreements will have a material adverse
effect on the Company's antisense research and development activities although a
requirement of the Company to pay the claimed amounts could have a material
adverse effect on its financial condition.
Other Anticode(TM) Antisense Agreements. The Company entered into
agreements with Johnson & Johnson Consumer Products, Inc. in late 1995 which
provided limited funding for preliminary feasibility studies using Genta's
Anticode(TM) oligonucleotide compounds. Another agreement entered into in 1991
with Procter and Gamble Company ended in 1995. Under the terms of these
agreements, if the collaborative partner elected to pursue the commercial
development of an Anticode(TM) oligonucleotide compound upon completion of the
feasibility studies, the parties would have entered into mutually acceptable
development, license and supply agreements. Neither of these collaborative
partners has indicated any interest in entering into such an agreement.
GENTA JAGO
In 1992, Genta and Jagotec determined to enter into a joint venture
(Genta Jago). The Company's purpose in establishing Genta Jago was to obtain a
limited-scope license to Jagotec's GEOMATRIX technology in the hopes of
producing shorter-term earnings than were expected from the Company's
Anticode(TM) antisense programs. Genta contributed $4 million in cash to Genta
Jago as well as the rights to apply its Anticode(TM) oligonucleotide technology
to six products and also contributed the Initial License referred to below.
Genta issued 120,000 shares of Common Stock valued at $7.2 million to Jagotec in
1992 as consideration for a license (the "Initial License") for Genta to use
Jagotec's GEOMATRIX technology with respect to approximately 25 products, under
the condition that Genta then contribute such technology to Genta Jago, which
Genta did. The value of the Common Stock Genta issued to Jagotec was considered
by the parties to be substantially below the actual fair market value of the
Initial License. Jagotec's contribution to the joint venture consisted of such
discount (coupled with the requirement that Genta contribute the Initial License
to the joint venture) as well as certain know-how applicable to the GEOMATRIX
technology.
In 1994, separate from the original 1992 joint venture agreement, Genta
and Jagotec began negotiations to expand Genta Jago to include the GEOMATRIX
technology as applied to 35 additional products (the "Additional License"). In
1994, Jagotec granted Genta, for $1.85 million, an option (the "Expansion
Option"), exercisable solely at Genta's discretion through April 30, 1995, to
expand the joint venture by purchasing from Jagotec the Additional License at
what the parties believed was a substantial
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discount to its actual fair market value on the condition that Genta then
contribute it to the joint venture. An additional $2.0 million (the "Deposit")
was deposited with Jagotec in 1994, but would only be retained by Jagotec, as
partial payment of the exercise price for the Expansion Option, if Genta
actually exercised the Expansion Option. If such Expansion Option was not
exercised, the $2.0 million Deposit would be transferred to Genta Jago in the
form of working capital loans payable by Genta Jago to Genta.
Pursuant to the terms of the Expansion Option, for Genta to exercise
the Expansion Option, Genta would have had to pay Jagotec an aggregate of $3.15
million in cash and 124,000 shares of Common Stock, valued at $1.6 million
(based on the trading price at such time). The parties agreed the $3.15 million
in cash would consist of (i) the $2.0 million Deposit made by Genta in 1994,
which would be applied to the Expansion Option's exercise price upon Genta's
election, in 1995, to exercise such Expansion Option; and (ii) an additional
cash payment of $1.15 million to exercise the Expansion Option to be paid by
Genta in 1995. In 1995, Genta exercised the Expansion Option.
The Company provides funding to Genta Jago pursuant to a working
capital loan agreement that expires in October 1998. See "MD&A--Liquidity and
Capital Resources." In 1995, Genta Jago returned the Anticode technology to
Genta in exchange for Genta's forgiveness of $4.7 million of principal and
interest outstanding under existing working capital loans to Genta Jago. This
amount was determined by an arm's- length negotiation between Genta, Jagotec,
and Genta Jago and was based on the amount actually expended by Genta Jago for
research and development related to the Anticode(TM) technology from the time
Genta Jago originally acquired the relevant license in 1992 through the date of
return in 1995.
Genta has the option (the "Purchase Option") to purchase Jagotec's
interest in Genta Jago during the period beginning on December 31, 1998 and
continuing through December 31, 2000 at a purchase price equal to the remainder
of (a) the sum of (i) the lesser of (x) 50% of the fair market value of Genta
Jago, excluding the fair market value of Genta Jago's rights to the Initial
License and the Additional License, or (y) $100 million, plus (ii) 50% of the
fair market value of Genta Jago's rights to the Initial License and the
Additional License, less (b) 1.714286 times the fair market value of the 70,000
shares of Common Stock issued to Jagotec pursuant to a Common Stock Transfer
Agreement dated as of December 15, 1992, between Genta and Jagotec.
Genta also has an exclusive worldwide license to use Jagotec's
GEOMATRIX technology in Genta's Anticode antisense development programs. Genta
Jago has contracted with Genta and Jagotec to conduct research and development
and to provide certain other services.
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The Company is currently in negotiations with Jagotec and its
affiliates to reach an agreement under which the terms of the joint venture
would be restructured. There can be no assurance that such negotiations will
result in a mutually satisfactory agreement.
Oral Controlled-Release Drugs
Formulations of drugs using the GEOMATRIX technology are designed to
swell and gel when exposed to gastrointestinal fluids. This swelling and gelling
is designed to allow the active drug component to diffuse from the tablet into
the gastrointestinal fluids, gradually over a period of up to 24 hours. The
Company believes that the GEOMATRIX technology may have other benefits that,
collectively, may distinguish it from competing controlled-release technologies.
More specifically, the Company believes these formulations can control drug
release and potentially modulate pharmacokinetic profiles to produce a variety
of desired clinical effects. For example, the GEOMATRIX technology may be used
to formulate tablets with a rapid or a delayed therapeutic effect by varying the
release characteristics of the drug from the tablet. The GEOMATRIX technology
may also be used to formulate tablets that release two drugs at the same or
different rates, or tablets that release a drug in several pulses after
administration.
Genta Jago is using the GEOMATRIX drug delivery technology to develop
oral controlled-release formulations for a broad range of presently marketed
drugs which have lost, or will, in the near to mid-term, lose patent protection
and/or marketing exclusivity. Certain of these presently marketed drugs are
already available in a controlled-release format, while others are only
available in an immediate release format that requires dosing several times
daily. In the case of drugs already available in a controlled-release format,
Genta Jago is seeking to develop bioequivalent products which would be
therapeutic substitutes for the branded products. In the case of currently
marketed products that are only available in immediate release form requiring
multiple daily dosing, Genta Jago is seeking to develop once or twice-daily
controlled-release formulations. The potential benefits of Genta Jago's oral
controlled-release formulations may include improved compliance, greater
efficacy and reduced side effects as a result of a more constant drug plasma
concentration than that associated with immediate release drugs administered
several times daily.
Genta Jago currently has eight products in various stages of
development that are intended to be bioequivalent generic versions of
brand-name, controlled-release drugs currently marketed by others. Four of these
products, nifedipine (Procardia XL(R)), ketoprofen (Oruvail(R)),
carbidopa/levodopa (Sinemet(R)CR), and naproxen (Naprelan(R)) are currently
undergoing manufacturing scale-up after completion of formulations development
and pilot human pharmacokinetic studies. During the manufacturing scale-up phase
of development, Genta Jago and its collaborators are seeking to proceed from the
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production of small-scale research quantities to the production of larger-scale
quantities necessary for commercial scale manufacturing. The scale-up has not
yet been successfully completed for these products. Assuming successful
completion of manufacturing scale-up, pivotal bioequivalency studies are
scheduled to begin for these products in 1998. Genta Jago believes that if such
bioequivalency studies are successfully completed, Abbreviated New Drug
Applications (each an "ANDA") may be filed with the FDA for two of its products
in 1998. In addition, potentially bioequivalent versions of two other
products--Voltaren-XR(R) (diclofenac) and Covera-HS(R) (verapamil)--have
completed formulations development and pilot pharmacokinetic studies. Genta Jago
intends to proceed with manufacturing scale-up on these two products during
1998. In December 1997, a competitor of the Company, Elan Corporation, received
approval of their ANDA for a generic formulation of Oruvail(R) (ketoprofen), and
another company, Mylan Laboratories, Inc., has filed an ANDA for a generic
formulation of Procardia XL(R) (nifedipine). See "MD&A--Certain Trends and
Uncertainties--Potential Adverse Effect of Technological Change and
Competition."
Genta Jago has also completed initial formulations development and
pilot human pharmacokinetic studies for GEOMATRIX controlled-release
formulations of cefaclor (Ceclor CD(R)) and metoprolol tartrate and formulations
development is ongoing for additional products including acyclovir (Zovirax(R)).
Genta Jago continues to seek collaborative agreements for these products in
order to finance the manufacturing scale-up and required bioequivalency or
clinical studies. In addition to these products currently in development, Genta
Jago maintains the rights to apply the GEOMATRIX technology to the development
of up to approximately 50 additional drugs. There can be no assurance that any
product will be successfully developed or receive the necessary regulatory
approvals.
Oral Controlled-Release Collaborative and Licensing Agreements
Genta Jago's strategy is to commercialize its GEOMATRIX
controlled-release products worldwide by forming alliances with pharmaceutical
companies. Genta Jago has established three such collaborations.
Genta Jago/Gensia/Brightstone. In January 1993, Genta Jago entered into
a collaboration agreement with Gensia for the development and commercialization
of certain oral controlled-release pharmaceutical products for treatment of
cardiovascular disease. Under the agreement, Gensia provides funding for
formulation and preclinical development to be conducted by Genta Jago and is
responsible for clinical development, regulatory submissions and marketing.
Terms of the agreement provide Gensia exclusive rights to market and distribute
the products in North America, Europe and certain other countries. The agreement
has a term of the longer of twelve years and the patent term in the respective
countries within the territory. Genta Jago received $1.2 million, $2.2 million
and $1.9 million of funding in 1997, 1996 and 1995, respectively, pursuant to
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the agreement. Collaborative revenues of $1.5 million, $2.8 million and $3
million were recognized under the agreement during the years ended December 31,
1997, 1996 and 1995, respectively. Effective October 1996, Gensia and SkyePharma
reached an agreement whereby a SkyePharma subsidiary, Brightstone Pharma, Inc.
("Brightstone"), was assigned Gensia's rights (and those of Gensia's partner,
Boehringer Mannheim) to develop and co-promote the potentially bioequivalent
nifedipine product under the collaboration agreement with Genta Jago. The
assignment was accepted by Genta Jago and has no impact on the terms of the
original agreement. Genta Jago is still entitled to receive additional milestone
payments from Brightstone triggered upon regulatory submissions and approvals,
as well as royalties or profit sharing ranging from 10% to 21% of product sales,
if any.
Genta Jago/Apothecon. In March 1996, Genta Jago entered into a
collaborative licensing and development agreement (the "Genta Jago/Apothecon
Agreement") with Apothecon, Inc. ("Apothecon"). Under the terms of the Genta
Jago/Apothecon Agreement, Apothecon will provide funding to Genta Jago up to a
specified maximum amount for the formulation of Q-CR ketoprofen (Oruvail(R)).
The Genta Jago/Apothecon Agreement expires upon the expiration of the relevant
patents in each covered country subject to certain early termination rights. The
agreement also provides for Genta Jago to receive potential milestone payments
and royalties on product sales. Terms of the agreement provide Apothecon
exclusive rights to market and distribute the products on a worldwide basis.
Genta Jago/Krypton. In October 1996, Genta Jago entered into five
collaborative licensing and development agreements (the "Genta Jago/Krypton
Agreements") with Krypton, Ltd. ("Krypton"), a subsidiary of SkyePharma, whereby
Genta Jago would sublicense to Krypton rights to develop and commercialize
potentially bioequivalent GEOMATRIX(R) versions of five currently marketed
products, as well as another agreement granting Krypton an option to sublicense
rights to develop and commercialize an improved version of a sixth product. The
Genta Jago/Krypton Agreements have terms of the shorter of fifteen years from
first commercial sale and the expiration of the patent term on a
territory-by-territory basis. During 1997, Genta Jago received funding of $1.9
million under the Genta Jago/Krypton Agreements and recognized $2.3 million of
collaborative revenue therefrom.
RESEARCH AND DEVELOPMENT
In an effort to focus its research and development efforts on areas
which provide the most significant commercial opportunities, the Company
continually evaluates its ongoing programs in light of the latest market
information and conditions, availability of third-party funding, technological
advances, and other factors. As a result of such evaluation, the Company's
product development plans have changed from time to time, and the Company
anticipates that they will continue to do so in the future. The Company
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recorded research and development expenses of $5.4 million, $6.8 million and
$13.1 million during 1997, 1996, and 1995, respectively, of which approximately
$50,000, zero dollars and $1.1 million, respectively, were funded pursuant to
collaborative research and development agreements and of which approximately
$0.3 million, $1.6 million and $2.7 million, respectively, were funded pursuant
to a related party contract revenue agreement with Genta Jago. See
"MD&A--Results of Operations."
MANUFACTURING/JBL
All of the Company's product sales are attributable to its
manufacturing subsidiary, JBL Scientific, Inc. ("JBL"). The products JBL
manufactures include: enzyme substrates that are used as color-generating
reagents in clinical diagnostic tests, such as pregnancy tests, developed by
JBL's customers; and fine chemical raw materials used in pharmaceutical research
and development and manufacturing, such as those used to make biological
polymers like peptides and oligonucleotides. JBL manufactures approximately
110-125 products on a recurring basis.
Genta obtained its manufacturing capabilities in early 1991 through the
acquisition of JBL. JBL is a manufacturer of high-quality specialty chemicals
and intermediate products for the pharmaceutical and in vitro diagnostic
industries. A number of Fortune 500 companies use JBL products as raw material
in the production of a final product. JBL markets its products to over 100
purchasers in the pharmaceutical and diagnostic industries. JBL might, with
additional capital investment, be able to manufacture commercial grade
oligonucleotides, including G3139. See "MD&A--Certain Trends and
Uncertainties--Difficult Manufacturing Process; Access to Certain Raw
Materials." JBL holds a California site license to manufacture drugs for use in
clinical research, but the manufacturing facilities at JBL have not been
inspected by the FDA for compliance with requirements for Good Manufacturing
Practices ("GMP"). The Company is continuing to review and develop procedures,
documentation and facilities for the production of oligonucleotides which it
believes will adequately comply with the necessary GMP requirements. The Company
is currently having G3139 made on a contract manufacturing basis by a third
party supplier. See "MD&A--Certain Trends and Uncertainties--Difficult
Manufacturing Process; Access to Certain Raw Materials." To the extent Genta is
able to establish its own manufacturing capability for G3139, the Company should
be able to reduce the cost of producing such oligonucleotides.
The manufacture of all of the Company's and Genta Jago's products will
be subject to GMP requirements prescribed by the FDA or other standards
prescribed by the appropriate regulatory agency in the country of use. There can
be no assurance that the Company or Genta Jago will be able to manufacture
products or have products manufactured for either of them in a timely fashion at
acceptable quality and prices, that they or third-party manufacturers can comply
with GMP, or that they or third-party
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manufacturers will be able to manufacture an adequate supply of product. Failure
to establish compliance with GMP to the satisfaction of the FDA can result in
delays in, or prohibition from, initiating clinical trials or commercial
marketing of a product.
GENTA EUROPE
During 1995, Genta Pharmaceuticals Europe S.A. ("Genta Europe")
received approximately 5.4 million French Francs (or, as of April 1, 1998,
approximately $869,000) of funding in the form of a loan from the French
government agency L'Agence Nationale de Valorisation de la Recherche ("ANVAR")
towards research and development activities pursuant to an agreement (the "ANVAR
Agreement") between ANVAR, Genta Europe and Genta. In October 1996, as part of
the Company's restructuring program, Genta Europe terminated all scientific
personnel. ANVAR asserted, in a letter dated February 13, 1998, that Genta
Europe was not in compliance with the ANVAR Agreement, and that ANVAR might
request the immediate repayment of such loan. The Company does not believe that
under the terms of the ANVAR Agreement ANVAR is entitled to request early
repayment and is working with ANVAR to achieve a mutually satisfactory
resolution.
SALES AND MARKETING
Genta Jago has secured collaborative agreements with three entities for
the development and commercialization of selected controlled-release
pharmaceuticals. See "Genta Jago--Oral Controlled-Release Collaborative and
Licensing Agreements." Genta Jago's collaborative agreements generally provide
the collaborative partner exclusive rights to market and distribute the products
in exchange for royalty payments to Genta Jago on product sales. Genta Jago's
goal is to form additional collaborations to develop and market a number of its
GEOMATRIX controlled-release products. There can be no assurance that any such
potential product will be successfully developed or that any prospective
collaborations or licensing arrangements will be entered into.
JBL manufactures and markets specialty biochemicals and intermediate
products to over 100 purchasers in the pharmaceutical and diagnostic industries,
with the top 10 customers representing more than 70% of JBL's total sales. JBL's
products are also sold to the academic, commercial and governmental research
markets primarily through distributors. In addition, JBL conducts contract
synthesis for pharmaceutical, diagnostic and industrial companies.
PATENTS AND PROPRIETARY TECHNOLOGY
The Company's policy is to protect its technology by, among other
things, filing patent applications with respect to technology considered
important to the development of its business. The Company also relies upon trade
secrets, unpatented
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know-how, continuing technological innovation and the pursuit of licensing
opportunities to develop and maintain its competitive position.
Genta has a portfolio of intellectual property rights to aspects of
oligonucleotide technology, which includes novel compositions of matter, methods
of large-scale synthesis, methods of controlling gene expression, and cationic
lipid compositions for delivery of oligonucleotides into cells. This portfolio
includes issued United States and Canadian patents and patent applications filed
by the Company. In addition, foreign counterparts of certain applications have
been filed or will be filed at the appropriate time. Allowed patents generally
would not expire until 17 years after the date of allowance if filed in the
United States before June 8, 1995 or, in other cases, 20 years from the date of
application. Generally, it is the Company's strategy to apply for patent
protection in the United States, Canada, Western Europe, Japan, Australia and
New Zealand.
Since its incorporation, Genta has separately filed an aggregate of
over 400 United States and foreign patent applications covering new compositions
and improved methods to use, synthesize and purify oligonucleotides, linker-arm
technology, and compositions for their delivery. Of these, over 280 are active.
Under the agreement with Gen-Probe, Genta gained non-exclusive access
to all technology developed by Gen-Probe, as of February 1989, related to the
use of DNA probes for therapeutic applications. This technology is related to
nucleic acid probes for quantitation of organisms and viruses, methods for their
production, including nonnucleotide linking reagents, labeling, and
purification, and methods for their use including hybridization and enhanced
hybridization. This includes rights to 14 issued patents and several pending
United States patent applications and corresponding issued and pending
applications in foreign countries. See "Genta Jago--Oligonucleotide
Collaborative and Licensing Agreements - Gen-Probe (Chugai)."
Genta also gained access to certain rights from the National Institutes
of Health ("NIH") covering phosphorothioate oligonucleotides. This includes
rights to three United States issued patents, one issued European patent and
other corresponding foreign applications that are still pending. In addition,
under an agreement with the University of Pennsylvania, Genta has acquired
exclusive rights to antisense oligonucleotides directed against the bcl-2 gene
as well as methods of their use for the treatment of cancer. On March 31, 1998,
the United States Patent and Trademark Office issued a patent included in the
Company's license agreement for claims covering antisense oligonucleotide
compounds targeted against the bcl-2 gene. These claims cover the Company's
proprietary Anticode(TM) oligonucleotide molecules which target the bcl-2 gene
including its lead clinical candidate, G3139. Other related United States and
corresponding foreign patent applications are still pending.
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Jagotec's GEOMATRIX technology is the subject of issued patents and
pending applications. Jagotec currently holds four issued United States patents,
five granted foreign patents, and other corresponding foreign patent
applications still pending that cover the GEOMATRIX technology. Certain rights
to GEOMATRIX technology have been licensed to Genta Jago. See "Genta Jago."
The patent positions of biopharmaceutical and biotechnology firms,
including Genta, can be uncertain and involve complex legal and factual
questions. Consequently, even though Genta is currently prosecuting its patent
applications with the United States and foreign patent offices, the Company does
not know whether any of its applications will result in the issuance of any
patents or if any issued patents will provide significant proprietary protection
or will be circumvented or invalidated. Since patent applications in the United
States are maintained in secrecy until patents issue, and since publication of
discoveries in the scientific or patent literature tend to lag behind actual
discoveries by several months, Genta cannot be certain that others have not
filed patent applications directed to inventions covered by its pending patent
applications or that it was the first to file patent applications for such
inventions.
Competitors or potential competitors may have filed applications for,
or have received patents and may obtain additional patents and proprietary
rights relating to, compounds or processes competitive with those of the
Company. See "Competition." Accordingly, there can be no assurance that the
Company's patent applications will result in issued patents or that, if issued,
the patents will afford protection against competitors with similar technology;
nor can there be any assurance that any patents issued to Genta will not be
infringed or circumvented by others; nor can there be any assurance that others
will not obtain patents that the Company would need to license or design around.
There can be no assurance that the Company will be able to obtain a license to
technology that it may require or that, if obtainable, such a license would be
available on reasonable terms.
There can be no assurance that the Company's patents, if issued, would
be held valid by a court of competent jurisdiction. Moreover, the Company may
become involved in interference proceedings declared by the United States Patent
and Trademark Office (or comparable foreign office or process) in connection
with one or more of its patents or patent applications to determine priority of
invention, which could result in substantial cost to the Company, as well as a
possible adverse decision as to priority of invention of the patent or patent
application involved.
The Company also relies upon unpatented trade secrets and no assurance
can be given that third parties will not independently develop substantially
equivalent proprietary information and techniques or gain access to the
Company's trade secrets or disclose such technologies to the public, or that the
Company can meaningfully maintain and protect unpatented trade secrets.
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Genta requires its employees, consultants, outside scientific
collaborators and sponsored researchers and other advisors to execute a
confidentiality agreement upon the commencement of an employment or consulting
relationship with the Company. The agreement generally provides that all
confidential information developed or made known to the individual during the
course of the individual's relationship with Genta shall be kept confidential
and shall not be disclosed to third parties except in specific circumstances. In
the case of employees, the agreement generally provides that all inventions
conceived by the individual shall be assigned to, and made the exclusive
property of, the Company. There can be no assurance, however, that these
agreements will provide meaningful protection for the Company's trade secrets or
adequate remedies in the event of unauthorized use or disclosure of such
information, or in the event of an employee's refusal to assign any patents to
the Company in spite of such contractual obligation. See "MD&A--Certain Trends
and Uncertainties--Uncertainty Regarding Patents and Proprietary Technology."
GOVERNMENT REGULATION
Regulation by governmental authorities in the United States and foreign
countries is a significant factor in the manufacture and marketing of the
Company's proposed products and in its ongoing research and product development
activities. All of the Company's therapeutic products will require regulatory
approval by governmental agencies prior to commercialization. In particular,
human therapeutic products are subject to rigorous preclinical and clinical
testing and premarket approval procedures by the FDA and similar authorities in
foreign countries. Various federal, and in some cases state, statutes and
regulations also govern or influence the manufacturing, safety, labeling,
storage, record keeping and marketing of such products. The lengthy process of
seeking these approvals, and the subsequent compliance with applicable federal,
and in some cases state, statutes and regulations, require the expenditure of
substantial resources. Any failure by the Company, its collaborators or its
licensees to obtain, or any delay in obtaining, regulatory approvals could
adversely affect the marketing of any products developed by the Company and its
ability to receive product or royalty revenue.
The activities required before a new pharmaceutical agent may be
marketed in the United States begin with preclinical testing. Preclinical tests
include laboratory evaluation of product chemistry and animal studies to assess
the potential safety and efficacy of the product and its formulations. The
results of these studies must be submitted to the FDA as part of an IND. An IND
becomes effective within 30 days of filing with the FDA unless the FDA imposes a
clinical hold on the IND. In addition, the FDA may, at any time, impose a
clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold,
clinical trials cannot commence or recommence, as the case may be, without prior
FDA authorization and then only under terms authorized by the FDA. Typically,
clinical testing involves a three-phase process. In Phase I, clinical trials are
conducted with a small number of subjects to determine the early safety profile
and the
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pattern of drug distribution and metabolism. In Phase II, clinical trials are
conducted with groups of patients afflicted with a specific disease in order to
determine preliminary efficacy, optimal dosages and expanded evidence of safety.
In Phase III, large-scale, multi-center, comparative clinical trials are
conducted with patients afflicted with a target disease in order to provide
enough data for the statistical proof of efficacy and safety required by the FDA
and others. In the case of products for life-threatening diseases, the initial
human testing is generally done in patients rather than in healthy volunteers.
Since these patients are already afflicted with the target disease, it is
possible that such studies may provide results traditionally obtained in Phase
II trials. These trials are frequently referred to as "Phase I/IIa" trials.
The results of the preclinical and clinical testing, together with
chemistry, manufacturing and control information, are then submitted to the FDA
for a pharmaceutical product in the form of a New Drug Application ("NDA"), for
a biological product in the form of a Product License Application ("PLA") or for
medical devices in the form of a Premarket Approval Application ("PMA") for
approval to commence commercial sales. In responding to an NDA, PLA or PMA, the
FDA may grant marketing approval, request additional information or deny the
application if it determines that the application does not satisfy its
regulatory approval criteria. There can be no assurance that approvals will be
granted on a timely basis, if at all, or if granted will cover all the clinical
indications for which the Company is seeking approval or will not contain
significant limitations in the form of warnings, precautions or
contraindications with respect to conditions of use.
In circumstances where a company intends to develop and introduce a
novel formulation of an active drug ingredient already approved by the FDA,
clinical and preclinical testing requirements may not be as extensive. Limited
additional data about the safety and/or effectiveness of the proposed new drug
formulation, along with chemistry and manufacturing information and public
information about the active ingredient, may be satisfactory for product
approval. Consequently, the new product formulation may receive marketing
approval more rapidly than a traditional full NDA, although no assurance can be
given that a product will be granted such treatment by the FDA.
For clinical investigation and marketing outside the United States, the
Company is or may be subject to foreign regulatory requirements governing human
clinical trials and marketing approval for drugs. The requirements governing the
conduct of clinical trials, product licensing, pricing and reimbursement vary
widely from country to country. The Company's approach is to design its European
clinical trials studies to meet FDA, European Economic Community ("EEC") and
other European countries' standards. At present, the marketing authorizations
are applied for at a national level, although certain EEC procedures are
available to companies wishing to market a product in more than one EEC member
state. If the competent authority is satisfied that adequate
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evidence of safety, quality and efficacy has been presented, a market
authorization will be granted. The registration system proposed for medicines in
the EEC after 1992 is a dual one in which products, such as biotechnology and
high technology products and those containing new active substances, will have
access to a central regulatory system that provides registration throughout the
entire EEC. Other products will be registered by national authorities under the
local laws of each EEC member state. With regulatory harmonization finalized in
the EEC, the Company's clinical trials will be designed to develop a regulatory
package sufficient for multi-country approval in the Company's European target
markets without the need to duplicate studies for individual country approvals.
This approach also takes advantage of regulatory requirements in some countries,
such as in the United Kingdom, which allow Phase I studies to commence after
appropriate toxicology and preclinical pharmacology studies, prior to formal
regulatory approval.
Prior to the enactment of the Drug Price Competition and Patent Term
Restoration Act of 1984 (the "Waxman/Hatch Act"), the FDA, by regulation,
permitted certain pre-1962 drugs to be approved under an abbreviated procedure
which waived submission of the extensive animal and human studies of safety and
effectiveness normally required to be in a NDA. Instead, the manufacturer only
needed to provide an Abbreviated New Drug Application ("ANDA") containing
labeling, information on chemistry and manufacturing procedures and data
establishing that the original "pioneer" product and the proposed "generic"
product are bioequivalent when administered to humans.
Originally, the FDA's regulations permitted this abbreviated procedure
only for copies of a drug that was approved by the FDA as safe before 1962 and
which was subsequently determined by the FDA to be effective for its intended
use. In 1984, the Waxman/Hatch Act extended permission to use the abbreviated
procedure established by the FDA to copies of post-1962 drugs subject to the
submission of the required data and information, including data establishing
bioequivalence. However, effective approval of such ANDAs were dependent upon
there being no outstanding patent or non-patent exclusivities.
Additionally, the FDA allows, under section 505(b)(2) of the Food Drug
and Cosmetic Act, for the submission and approval of a hybrid application for
certain changes in drugs which, but for the changes, would be eligible for an
effective ANDA approval. Under these procedures the applicant is required to
submit the clinical efficacy and/or safety data necessary to support the changes
from the ANDA eligible drug (without submitting the basic underlying safety and
efficacy data for the chemical entity involved) plus manufacturing and chemistry
data and information. Effective approval of a 505(b)(2) application is dependent
upon the ANDA-eligible drug upon which the applicant relies for the basic safety
and efficacy data being subject to no outstanding patent or non-patent
exclusivities. As compared to a NDA, an ANDA or a 505(b)(2)
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application typically involves reduced research and development costs. However,
there can be no assurance that any such applications will be approved.
Furthermore, the supply of raw materials must also be approved by the FDA.
The Company is also subject to various foreign, federal, state and
local laws, regulations and recommendations relating to safe working conditions,
laboratory and manufacturing practices, the experimental use of animals and the
use, manufacture, storage, handling and disposal of hazardous or potentially
hazardous substances, including radioactive compounds and infectious disease
agents, used in connection with the Company's research and development work and
manufacturing processes. Although the Company believes it is in compliance with
these laws and regulations in all material respects (except as disclosed under
"MD&A--Liquidity and Capital Resources"), there can be no assurance that the
Company will not be required to incur significant costs to comply with such
regulations in the future. See "MD&A--Certain Trends and Uncertainties--No
Assurance of Regulatory Approval; Government Regulation."
COMPETITION
For many of their applications, the Company's and Genta Jago's products
under development will be competing with existing therapies for market share. In
addition, a number of companies are pursuing the development of antisense and
triple-strand technology and controlled-release formulation technology and the
development of pharmaceuticals utilizing such technologies. The Company competes
with fully integrated pharmaceutical companies which have more substantial
experience, financial and other resources and superior expertise in research and
development, manufacturing, testing, obtaining regulatory approvals, marketing
and distribution. Smaller companies may also prove to be significant
competitors, particularly through their collaborative arrangements with large
pharmaceutical companies or academic institutions. Furthermore, academic
institutions, governmental agencies and other public and private research
organizations have conducted and will continue to conduct research, seek patent
protection and establish arrangements for commercializing products. Such
products may compete directly with any products that may be offered by the
Company. In December 1997, a competitor of the Company, Elan Corporation
received approval of their ANDA for a generic formulation of Oruvail(R)
(ketoprofen), and another company, Mylan Laboratories, Inc., has filed an ANDA
for a generic formulation of procardia XL(R) (nifedipine). See "MD&A--Certain
Trends and Uncertainties--Potential Adverse Effect of Technological Change and
Competition."
The Company's products under development are expected to address an
array of markets. The Company's competition will be determined in part by the
potential indications for which the Company's products are developed and
ultimately approved by regulatory authorities. For certain of the Company's
potential products, an important factor in competition may be the timing of
market introduction of the Company's or
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competitors' products. See "MD&A--Certain Trends and Uncertainties--Potential
Adverse Effect of Technological Change and Competition." Accordingly, the
relative speed with which Genta and Genta Jago can develop products, complete
the clinical trials and approval processes and supply commercial quantities of
the products to the market are expected to be important competitive factors. The
Company expects that competition among products approved for sale will be based,
among other things, on product efficacy, safety, reliability, availability,
price, patent position and sales, marketing and distribution capabilities. The
development by others of new treatment methods could render the Company's and
Genta Jago's products under development non-competitive or obsolete.
The Company's competitive position also depends upon its ability to
attract and retain qualified personnel, obtain patent protection or otherwise
develop proprietary products or processes and secure sufficient capital
resources for the often substantial period between technological conception and
commercial sales. See "MD&A--Certain Trends and Uncertainties--Need for and
Dependence on Qualified Personnel," "MD&A-- Certain Trends and
Uncertainties--Uncertainty Regarding Patents and Proprietary Technology" and
"MD&A--Certain Trends and Uncertainties--Need for Additional Funds; Risk of
Insolvency."
JBL's products address several markets, including clinical chemistry,
diagnostics, molecular biology and pharmaceutical development. While many
customers have specified JBL products in their manufacturing protocols,
competition from several international competitors, many of whom have more
substantial experience, financial and other resources and superior expertise in
research and development, manufacturing, testing, obtaining regulatory
approvals, marketing and distribution, could undermine JBL's competitive
position. Competition has come primarily on price for some key JBL products for
pharmaceutical development, and from competing technologies in diagnostics and
molecular biology.
HUMAN RESOURCES
As of December 31, 1997, Genta, JBL and Genta Europe had nine, 40 and
one employees, respectively, nine of whom held doctoral degrees. Seventeen
employees were engaged in research and development activities, 19 were engaged
in manufacturing and 13 were in administration, sales and marketing positions.
Most of the management and professional employees of the Company and JBL have
had prior experience and positions with pharmaceutical and biotechnology
companies. Genta believes it maintains satisfactory relations with its
employees.
In 1997, the Company terminated 11 employees and Genta Europe
terminated one employee. The Company's overall staff was reduced by an
additional net reduction of three employees in 1997, and two more to date in
1998, due to attrition. See
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"MD&A--Certain Trends and Uncertainties--Need for and Dependence on Qualified
Personnel."
ITEM 2. PROPERTIES
Genta's principal administrative offices are located in San Diego,
California where the Company occupied approximately 8,500 square feet. Effective
March 1, 1998, the Company reduced its leased space in San Diego to 4,732 square
feet and closed its laboratory facilities at this site. The Company's revised
lease for these remaining administrative office facilities extends through
August 1998, with the option for additional three-month extensions at the same
rate of $6,073 per month. The Company believes this space will be adequate for
its activities through 1998.
JBL, the Company's manufacturing subsidiary, leases and occupies
approximately 30,000 square feet of office, laboratory and manufacturing space
in San Luis Obispo, California. This lease expires in 2000. The lease calls for
rent of approximately $321,500 in 1998, with amounts generally increasing
annually thereafter to reflect cost of living related increases. The Company
currently uses substantially all of the manufacturing capacity of this facility.
The Company believes that such space will be adequate for its planned operations
through 1998. The Company also has an option to purchase property adjacent to
this facility, for expansion, if necessary. A director and officer and another
officer of the Company, Drs. Klem and Brown, respectively, are affiliated with
the owners of the leased and adjacent properties.
Genta Pharmaceuticals Europe, S.A., the Company's European subsidiary,
leases approximately 10,000 square feet of office, laboratory and manufacturing
space in Marseilles, France. The lease is cancelable in 2003 and expires in
2005. The annual lease cost is F.F. 575,319 (or, as of April 1, 1998,
approximately $93,000). With the reduction of its operations, Genta Europe is
currently seeking to sublet all or a portion of this space.
ITEM 3. LEGAL PROCEEDINGS
(a) On February 5, 1997, Equity-Linked Investors, L.P. and
Equity-Linked Investors-II (collectively, the "Plaintiffs") who, as a group, may
be deemed beneficially to own more than five percent of the outstanding shares
of the Common Stock of the Company as holders of Series A Preferred Stock, filed
suit (the "Suit") in the Delaware Court of Chancery (the "Court") against the
Company, each of the Company's directors and the Aries Funds (as hereinafter
defined in Item 5). Through the Suit, the Plaintiffs sought to enjoin the
transactions contemplated by The Note and Warrant Purchase Agreement (as
hereinafter defined in Item 5) (the "Transactions"), rescission of the
Transactions, damages, attorney fees, and such other and further relief as the
Court may deem just and proper. The Suit alleged that the Board of Directors of
the Company
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<PAGE>
breached fiduciary duties by failing to consider financing alternatives to the
Transactions and further alleged that the Transactions were not in the best
interests of the stockholders. Additionally, the Suit alleged that the Aries
Funds aided and abetted such breach of fiduciary duty through their
participation in the Transactions. On March 4 and 5, 1997, a trial was held
before the Court. On April 25, 1997, the Court rejected the plaintiffs'
challenge to the Transactions and ruled in favor of Genta, Genta's directors and
the Aries Funds, who were the defendants. The Court entered a judgment in favor
of Genta and its directors in the Suit.
LBC Capital Resources, Inc. ("LBC"), a Philadelphia-based broker/dealer
has asserted claims against the Company and others. LBC's claims relate to the
alleged breach by the Company of certain letter agreements, allegedly entered
into by LBC and the Company in 1995 and 1996 with respect to brokerage and/or
investment banking services particularly in connection with a $3 million
investment for which LBC is seeking a fee. On March 30, 1998, the Company
received a Statement of Claim under NASD arbitration rules, and a request that
the Company voluntarily submit to NASD arbitration. The Company has not yet
responded to that request. LBC's Statement of Claim seeks damages in the form of
cash (in excess of $4 million), stock, warrants and other securities. On April
9, 1998, the Company's counsel learned that, in addition, a Complaint has been
filed in the United States District Court for the Southern District of New York
(98 Civ. 2491) by LBC against the Company and the same other parties. However,
such Complaint has not yet been served upon the Company. The Company believes it
has valid legal and equitable defenses to LBC's claim. Whether LBC's claims are
ultimately adjudicated in arbitration or litigation, the Company intends to
defend vigorously and possibly to assert counterclaims against LBC.
(b) No material legal proceedings were terminated in the quarter ending
December 31, 1997.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders in the quarter
ended December 31, 1997.
Executive Officers of the Registrant
The executive officers of the Company are as follows:
Name Age Position
Kenneth G. Kasses, Ph.D 53 President, Chief
Executive Officer and
Director of the Company
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<PAGE>
Robert E. Klem, Ph.D. 53 Vice President and
Director of the Company
and Chairman of the
Board of JBL
Lauren R. Brown, Ph.D. 55 Vice President of the
Company and President of
JBL
Kenneth G. Kasses, Ph.D., is Genta's President, Chief Executive Officer
and a member of the Board of Directors. From 1991-1997, Dr. Kasses was
affiliated with the Radiopharmaceutical Division of The DuPont Merck
Pharmaceutical Company, serving as Senior Vice President and General Manager
until 1994 when he was appointed President. From 1988 through 1990, he served as
Director, Business Development and Planning, for the Medical Products Department
of E. I. duPont de Nemours & Company, Inc. In that capacity he played a key role
in the formation of The DuPont Merck Pharmaceutical Company, a joint venture
between DuPont and Merck and Co., Inc. Prior to that he served as Director, U.S.
Pharmaceuticals, for DuPont from 1987-1988 and as President of DuPont Critical
Care from 1986-1987. Prior to this, Dr. Kasses held a variety of executive
positions from 1973-86 at American Critical Care, CIBA-GEIGY Pharmaceuticals,
Ayerst Laboratories and Block Drug Company. Dr. Kasses received a B.S. in
biology from Dickinson College in 1966 and a Ph.D. in pharmacology from New York
Medical College in 1974. Dr. Kasses also currently serves on the Board of
Directors of the United Way of Merrimack Valley (Mass.).
Robert E. Klem, Ph.D., has been a director of the Company since
February 1991, a Vice President of the Company since October 1991 and is
currently the Company's Principal Accounting Officer. Dr. Klem co-founded JBL
Scientific, Inc. ("JBL"), a wholly owned subsidiary of the Company, in 1973 and,
since then, has been Chairman of the Board and Chief Technical Officer of JBL
with overall managerial responsibility for JBL. Previously, Dr. Klem was the
Plant Manager for The DuPont Company in Victoria, Texas from 1970 to 1974. Dr.
Klem received his Ph.D. in Organic Chemistry from the University of California
at Riverside.
Lauren R. Brown, Ph.D., has been a Vice President of the Company since
October 1991. He co-founded JBL Scientific in 1973 and since then has been
President of JBL, which Genta acquired in February 1991. He has had significant
experience in the scale-up of a wide variety of processes, including many custom
syntheses under GMP standards for outside companies. Present responsibilities
include oversight of sales and marketing, quality control and process
development programs as well as participating in the overall management of JBL.
Dr. Brown received his Ph.D. in Organic Chemistry from the University of
California at Riverside. He is active in community affairs in San Luis Obispo
and presently serves on the Boards for the YMCA and the Chamber of Commerce.
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<PAGE>
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED
STOCKHOLDER MATTERS
(a) Market Information
Throughout 1996 and in the beginning of 1997, the Company's common
stock was traded on the Nasdaq National Market under the symbol "GNTA."
Beginning February 7, 1997, the Company's common stock traded in the
over-the-counter market on the Nasdaq SmallCap Market, initially under the
symbol "GNTAC." During the 20 trading days immediately following the Company's
reverse stock split effected on April 7, 1997, the Company's common stock traded
under the symbol "GNTCD." Genta resumed trading under the symbol "GNTA" on July
24, 1997, after having met the terms for continued listing as set forth in the
April 11, 1997 revised exception of the Nasdaq Listing Qualifications Panel. The
following table sets forth, for the periods indicated, the high and low sales
prices for the common stock as reported by Nasdaq (as adjusted for the Reverse
Stock Split).
High Low
---- ---
1996
First Quarter 29 3/8 18 3/4
Second Quarter 28 3/4 14 3/8
Third Quarter 20 4 3/8
Fourth Quarter 15 2 13/16
1997
First Quarter 9 11/16 2 1/2
Second Quarter 6 1/2 1 3/4
Third Quarter 3 3/4 1 5/16
Fourth Quarter 2 3/4 25/32
(b) Holders
There were 337 holders of record of the Company's common stock as of
April 10, 1998.
(c) Dividends
The Company has never paid cash dividends on its common stock and does
not anticipate paying any such dividends in the foreseeable future. In addition,
the Company is restricted from paying cash dividends on its common stock until
such time
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<PAGE>
as all cumulative dividends have been paid on outstanding shares of its Series A
and Series D convertible preferred stocks. The Company currently intends to
retain its earnings, if any, after payment of dividends on outstanding shares of
Series A and Series D convertible preferred stock, for the development of its
business. See "MD&A--Liquidity and Capital Resources."
(d) Recent Sales Of Unregistered Securities
In February 1997, the Company raised gross proceeds of $3 million in a
private placement, to The Aries Fund, a Cayman Islands Trust and the Aries
Domestic Fund, L.P. (collectively the "Aries Funds"), of Convertible Notes and
warrants to purchase common stock ("Bridge Warrants"). The Convertible Notes,
together with accrued interest thereon, were converted pursuant to their terms
into an aggregate of 65,415 shares of Series D Preferred Stock, which in turn
are convertible, at $0.94375 per share, into 6,931,391 shares of common stock.
The Bridge Warrants permit the purchase of up to an aggregate of 6,357,616
shares of Common Stock at an exercise price of $0.471875 per share (subject to
adjustment upon the occurrence of certain events). Pursuant to the Note and
Warrant Purchase Agreement dated as of January 28, 1997 between the Company and
the Aries Funds (the "Note and Warrant Purchase Agreement"), the Aries Funds
have the right to appoint a majority of the members of the Board of Directors of
the Company. See "MD&A--Certain Trends and Uncertainties--Certain Interlocking
Relationships; Potential Conflicts of Interest."
On June 6, 1997, the Aries Funds entered into a Line of Credit
Agreement with the Company pursuant to which the Aries Funds provided the
Company with a line of credit of up to $500,000, which subsequently was repaid,
in consideration for warrants (the "Line of Credit Warrants") to purchase 50,000
shares of Common Stock exercisable at $2.50 per share, subject to adjustment
upon the occurrence of certain events.
As of August 27, 1997, the Company entered into separate consulting
agreements with each of Dr. Paul O.P. Ts'o and Dr. Sharon B. Webster (both
former directors of the Company), pursuant to which, in addition to certain
other compensation for consulting services to be rendered thereunder, the
Company issued 15,400 shares of Common Stock to Dr. Ts'o and 15,500 shares of
Common Stock to Dr. Webster.
On June 30, 1997, a total of 161.58 Premium Preferred UnitsTM ("Units")
were sold to accredited investors in a private placement (the "Private
Placement"). Such sale was made in reliance on the exemption from registration
pursuant to Rule 506 of Regulation D of the Securities Act. Each unit sold in
the Private Placement consists of 1,000 shares of Premium Preferred StockTM, par
value $0.001 per share, stated value $100.00 per share, and warrants to purchase
5,000 shares of the Company's common stock, par value $0.001 per share, at any
time prior to the fifth anniversary of the final closing date. A total of
$16,158,000 was raised. The net proceeds to the Company were
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<PAGE>
$14,036,772. The respective conversion and exercise prices of the Series D
Preferred Stock and the Class D Warrants is $0.94375 per share of common stock,
subject to adjustment upon the occurrence of certain events. In connection with
the Private Placement, the placement agent -- Paramount Capital, Inc. --
received cash commissions equal to 9% of the gross sales price and a
non-accountable expense allowance equal to 4% of the gross sales price, and the
placement agent received warrants (the "Placement Warrants") to purchase up to
10% of the Units sold in the Private Placement for 110% of the offering price
per Unit. Furthermore, the Company has agreed to enter into a financial advisory
agreement with the placement agent pursuant to which the financial advisor shall
receive certain cash fees and has received warrants (the "Advisory Warrants") to
purchase up to 15% of the Units sold in the Private Placement for 110% of the
offering price per Unit.
The Company was contractually required to file, and has filed, a
Registration Statement on Form S-3 with the Securities and Exchange Commission
(the "SEC") under the Securities Act with respect to the common stock issuable
upon conversion and upon exercise of the securities issued in the private
placement consummated in February 1997 and the Private Placement. The SEC has
not yet declared this registration statement effective. There can be no
assurance that such registration statement will ever become effective or that
any delay or failure to have such registration statement declared effective will
not have a material adverse effect on the Company. See "MD&A--Certain Trends and
Uncertainties--Subordination of Common Stock to Series A and Series D Preferred
Stock; Risk of Dilution; Anti-Dilution Adjustments."
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<PAGE>
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
<TABLE>
<CAPTION>
YEARS ENDED DECEMBER 31,
--------------------------------------------------------
1997 1996 1995 1994 1993
-------- -------- -------- -------- --------
(In thousands, except per share amounts)
CONSOLIDATED STATEMENTS
OF OPERATIONS DATA:
<S> <C> <C> <C> <C> <C>
Product sales $ 4,702 $ 4,925 $ 3,782 $ 3,574 $ 3,263
Gain on sale of technology -- 373 -- -- --
Related party contract revenue 350 1,559 2,748 2,957 --
Collaborative research and
development 50 -- 1,125 3,142 4,733
-------- -------- -------- -------- --------
5,102 6,857 7,655 9,673 7,996
-------- -------- -------- -------- --------
Costs and expenses:
Cost of products sold 3,099 2,479 1,899 1,710 1,593
Research and development 5,387 6,777 13,103 15,835 12,117
Charge for acquired in-process
research and development -- -- 4,762 1,850 --
Selling, general and administrative 8,075 6,255 6,361 7,032 5,140
-------- -------- -------- -------- --------
16,561 15,511 26,125 26,427 18,850
-------- -------- -------- -------- --------
Loss from operations (11,459) (8,654) (18,470) (16,754) (10,854)
Equity in net loss of joint venture (1,193) (2,712) (6,913) (7,425) (5,310)
Other income, net (2,773) (726) 17 731 646
-------- -------- -------- -------- --------
Net loss $(15,425) $(12,092) $(25,366) $(23,448) $(15,518)
Dividends on Preferred Stock (1,695) (2,525) (2,551) (2,550) (671)
Dividends imputed on preferred stock (16,158) (2,348) $ (1,000) -- --
-------- -------- -------- -------- --------
Net loss applicable to common shares $(33,278) $(16,965) $(28,917) $(25,998) $(16,189)
-------- -------- -------- -------- --------
Net loss per common Share (1) $ (7.52) $ (5.69) $ (14.82) $ (19.00) $ (11.90)
-------- -------- -------- -------- --------
Shares used in the calculation of net
loss per common share 4,422 2,983 1,952 1,371 1,362
-------- -------- -------- -------- --------
Deficiency of earnings to meet
combined fixed charges and
preferred stock dividends (2) $(33,278) $(16,965) $(28,917) $(25,998) $(16,189)
<CAPTION>
DECEMBER 31,
--------------------------------------------------------------------------------
1997 1996 1995 1994 1993
---- ---- ---- ---- ----
(In thousands)
CONSOLIDATED BALANCE
SHEET DATA:
<S> <C> <C> <C> <C> <C>
Cash, cash equivalents and short-term
investments $8,456 $832 $272 $11,103 $34,594
Working capital (deficit) 5,807 (2,995) (1,580) 5,597 30,524
Total assets 15,754 11,169 15,631 23,808 45,486
Notes payable and capital lease
obligations, less current portion -- 120 2,334 1,871 1,651
Total Stockholders' equity 6,425 4,074 6,972 15,496 38,064
</TABLE>
(1) Computed on the basis of net loss per common share described in Note 1 of
Notes to Consolidated Financial Statements
(2) The Company has incurred losses and, thus, has had a deficiency in fixed
charges and preferred stock dividend coverage since inception.
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<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
OVERVIEW
Since its inception in February 1988, Genta has devoted its principal
efforts toward drug discovery, research and development. Genta has been
unprofitable to date and, even if it obtains financing to continue its
operations, expects to incur substantial operating losses for the next several
years due to continued requirements for ongoing research and development
activities, preclinical and clinical testing, manufacturing activities,
regulatory activities, establishment of a sales and marketing organization, and
development activities undertaken by Genta Jago, the Company's joint venture
with Jagotec. From the period since its inception to December 31, 1997, the
Company has incurred a cumulative net loss of $124.5 million. The Company has
experienced significant quarterly fluctuations in operating results and it
expects that these fluctuations in revenues, expenses and losses will continue.
The Company's independent auditors have included an explanatory
statement in their report to the Company's financial statements at December 31,
1997, that expresses substantial doubt as to the Company's ability to continue
as a going concern. There are several factors that must be considered risks in
that regard and those that are known to management are discussed in
"MD&A--Certain Trends and Uncertainties."
The statements contained in this Annual Report on Form 10-K/A that are not
historical are forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, including statements regarding the
expectations, beliefs, intentions or strategies regarding the future. The
Company intends that all forward-looking statements be subject to the
safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements reflect the Company's views as of the date they
are made with respect to future events and financial performance, but are
subject to many risks and uncertainties, which could cause the actual results of
the Company to differ materially from any future results expressed or implied by
such forward-looking statements. Examples of such risks and uncertainties
include, but are not limited to, obtaining sufficient financing to maintain the
Company's planned operations, the timely development, receipt of necessary
regulatory approvals and acceptance of new products, the successful application
of the Company's technology to produce new products, the obtaining of
proprietary protection for any such technology and products, the impact of
competitive products and pricing and reimbursement policies, changing market
conditions and the other risks detailed in the Certain Trends and Uncertainties
section of this Management's Discussion and Analysis of Financial Condition and
Results of Operations and elsewhere in this Annual Report on Form 10-K/A. The
Company does not undertake to update any forward-looking statements.
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<PAGE>
RESULTS OF OPERATIONS
Operating revenues totaled $5.1 million in 1997 compared to $6.9
million in 1996 and $7.7 million in 1995. The decreases in revenues over this
period is primarily attributable to decreases in revenues from Genta Jago for
services provided to Genta Jago by the Company. These "Related party contract
revenues" were $350,000 in 1997, $1.6 million in 1996, and $2.7 million in 1997.
The expenses for which these revenues are received are recorded as Costs and
Expenses in the same period such that the net effect on Genta's consolidated
statements is zero (see below). It is anticipated that as the Company has
reduced its resources and focused them on its development of its lead Anticode
oligonucleotide, G3139, this trend will continue in that the Company will
continue to minimize the services it provides to Genta Jago. It should be noted
that at the same time, the Company is also reducing its commitment to provide
funds to Genta Jago. The Company is currently in negotiations with Jagotec and
its affiliates to reach an agreement under which the terms of the joint venture
would be restructured. There can be no assurance that such negotiations will
result in a mutually satisfactory agreement.
Collaborative research and development revenues were $50,000 in 1997,
representing deferred revenues recognized pursuant to the Company's
collaboration with Johnson & Johnson Consumer Products, Inc., and $1.1 million
in 1995, earned through the collaboration with The Procter & Gamble Company. See
"Business--Anticode(TM) Brand of Antisense Oligonucleotide
Programs--Oligonucleotide Collaborative and Licensing Agreements--Other Anticode
Agreements." Both of these agreements have ended and there have been no
indications that either will produce additional revenues in the future.
All of the Company's product sales are attributable to JBL. Sales of
specialty chemical and pharmaceutical intermediate products used in the clinical
diagnostics, pharmaceutical research and development and pharmaceutical
manufacturing decreased to $4.7 million in 1997 from $4.9 million in 1996 and
were $3.8 million in 1995. While the annual demand for many of JBL's products is
relatively stable, there has been a slight downward trend for clinical
diagnostic raw materials and an upward trend for research and development and
pharmaceutical manufacturing raw materials. Overall, demand for the Company's
products has been increasing, while competition has caused prices to decrease.
In 1995 and 1996, sales of products used in pharmaceutical manufacturing and
pharmaceutical research and development increased due to increased market
penetration while sales of products used in clinical diagnostics trended
slightly downward. In 1997, demand for the Company's products continued to
increase, particularly intermediates used in pharmaceutical research and
development and pharmaceutical manufacturing; however, competition caused sales
prices to decrease.
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<PAGE>
Europa Bioproducts ("Europa"), JBL's European distributor, accounted
for approximately 25%, of product sales in 1997, 27% in 1996, and 21% in 1995.
No other customer accounted for more than 10% of product sales in 1997. One
other customer who accounted for less than 10% of product sales in 1997
accounted for approximately 16% of product sales during the year ended December
31, 1995. Individual customers' demands for JBL products generally fluctuates
with the outcomes of clinical trials or the availability of funding. The Company
believes that the loss of any material customer, if not replaced, could have an
adverse effect on the Company.
Costs and expenses totaled $16.6 million in 1997 compared to $15.5
million in 1996 and $26.1 million in 1995. Over this period the costs of
products sold by JBL have increased as market penetration and volumes increased.
The increase in costs of products sold in 1997 as compared to 1996 was due to
increased labor costs necessary to meet increased production volumes and to the
redeployment of certain employees in connection with a reduction in Genta's
research and development staff. As a result of these increased costs and reduced
selling prices in response to competition, gross margins decreased from 50% in
1995 and 1996 to 34% in 1997.
Research and Development expenses as a whole were reduced in 1996 from
the prior year by $6.3 million (48%) and an additional $1.4 million (21%) in
1997. The decrease in research and development expenses is primarily
attributable to the Company's restructuring and the redeployment of certain
employees mentioned above, and related workforce reductions implemented in 1995,
1996 and 1997 (see below) together with the discontinuation or non-initiation of
several programs. Research and development and certain other services the
Company provided to Genta Jago under the terms of the joint venture were
significantly reduced over the period from 1995 through 1997. These amounts were
$2.7 million in 1995, $1.6 million in 1996, and $350,000 in 1997 (see above).
Also included in Research and Development expenses during 1995 were non-
recurring charges for acquired in-process research and development totaling $4.8
million associated with the expansion of Genta Jago to obtain rights to develop
additional GEOMATRIX-based products. The technological feasibility of the
acquired in-process research and development had not yet been established and
the technology had no future alternative uses at the date of acquisition.
Furthermore, due to uncertainties regarding the Company's ability to demonstrate
bioequivalence of potential products, management is unable to make estimates
regarding the efforts necessary to develop the acquired, in-process technology
into a commercially viable product. However, it is expected that any such
development would require significant cash resources.
In an effort to focus its research and development efforts on areas
that provide the most significant commercial opportunities, the Company
continually evaluates its ongoing programs in light of the latest market
information and conditions, availability of third-party funding, technological
advances, and other factors. As a result of such evaluation, the
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<PAGE>
Company's product development plans have changed from time to time, and the
Company anticipates that they will continue to do so in the future.
In total, the Company's costs and expenses increased by approximately
$1.0 million in 1997 relative to 1996. The decreases in research and development
expenses described above were partially offset by a $600,000 non-recurring
charge in General and Administrative Expenses recorded in the third quarter of
1997 related to management's decision to abandon certain patents that management
determined were no longer germane to the Company's mainstream business (see
below). In addition, General & Administrative Expenses also increased as a
result of increased legal expenses associated with successfully defending the
litigation brought by certain of the Company's preferred stockholders
challenging a $3.0 million investment made in February 1997, which litigation
was resolved in the Company's favor in April 1997; increased accounting and
legal expenses due to the Company's successful efforts to avoid a potential
Nasdaq delisting and associated with the equity offerings consummated in 1997;
and increased recruiting expenses. See "Legal Proceedings" and "Market for
Registrant's Common Equity and Related Stockholder Matters -- Recent Sales of
Unregistered Securities."
As noted above, in an effort to reduce costs and conserve working
capital, Genta initiated a termination plan in March 1995, whereby the Company
terminated 26 employees involved in the Company's research and development
activities. The Company recorded General and Administrative expenses totaling
$250,000 for accrued severance costs associated with the 26 terminated
employees. In October 1996, Genta again reassessed its personnel requirements
and established a second termination plan whereby the Company terminated 16
research and administrative employees and recorded General and Administrative
expenses of $850,000 for accrued severance. In May 1997, Genta again reassessed
its personnel requirements and established a third termination plan involving
the termination of 12 research and administrative employees. The Company
recorded General and Administrative expenses of $868,000 in the second quarter
of 1997 for accrued severance costs. The Company has reduced its work force to a
core group of corporate personnel to maintain Genta's operations in the
development of G3139. Chemical and manufacturing development and quality
assurance and control is managed or conducted at JBL, in coordination with
Genta's core staff.
Services and capabilities that have not been retained within the
Company are out- sourced through short-term contracts or from consultants. All
preclinical biology and clinical trial work is now conducted through such
collaborations with external scientists and clinicians. The Company anticipates
that, if sufficient collaborative revenues and other funding are available,
research and development expenses may increase in future years due to
requirements for preclinical studies, clinical trials, the G3139 Anticode
oligonucleotide program and increased regulatory costs. The Company will be
required to assess the potential costs and benefits of developing its own
Anticode(TM) oligonucleotide manufacturing, marketing and sales activities if
and as such products are successfully
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<PAGE>
developed and approved for marketing, as compared to establishing a corporate
partner relationship .
The Company's policy is to evaluate the appropriateness of carrying
values of the unamortized balances of intangible assets on the basis of
estimated future cash flows (undiscounted) and other factors. If such evaluation
were to indentify a material impairment of these intangible assets, such
impairment would be recognized by a write- down of the applicable assets. The
Company continues to evaluate the continuing value of patents and patent
applications, particularly as expenses to prosecute or maintain these patents
come due. Through this evaluation, the Company may elect to continue to maintain
these patents; seek to out-license them; or abandon them. In 1997, as a result
of such evaluation, the Company recorded charges to General & Administrative
Expenses of $600,000 to account for the value of the abandoned patents no longer
related to the research and development efforts of the Company.
The Company's equity in net loss of joint venture (Genta Jago) totaled
$1.2 million in 1997 compared to $2.7 million in 1996 and $6.9 million in 1995.
The decrease in the Company's equity in net loss of joint venture during 1997
relative to 1996 is largely attributable to the fact that development efforts
are now focused exclusively on GEOMATRIX-based products and a greater portion of
development activities were funded pursuant to Genta Jago's collaborative
agreements with third parties. The operating results of Genta Jago are based
primarily on three factors. First, Genta Jago receives collaborative research
and development revenue from third parties. Secondly, Genta Jago is billed by
Jagotec and Genta for research and development costs associated with Genta Jago
projects. Thirdly, there are general and administrative costs associated with
the joint venture. Through May 1995, Genta Jago's development efforts were not
strictly GEOMATRIX-based products. Genta Jago also had the right to develop six
Anticode(TM) oligonucleotide products licensed from Genta. However, in 1995 the
parties elected to focus Genta Jago's activities exclusively on GEOMATRIX-based
products. In connection with the return of the Anticode(TM) oligonucleotide
technology license rights to Genta in May 1995, Genta Jago's note payable to
Genta was credited with approximately $4.7 million in principal and accrued
interest. Genta Jago recorded the loan credit and related accrued interest as a
gain on waiver of debt in exchange for return of license rights to related
party. Furthermore, since Genta Jago was no longer responsible for developing
Anticode(TM) oligonucleotide products, its future working capital requirements
were reduced. The equity in net loss of joint venture is determined by reducing
the loss per Genta Jago financials by Genta's 20% markup on internal costs for
which the joint venture is billed plus the interest accrued on the working
capital loans.
Since the formation of Genta Jago, no products have been successfully
developed and marketed. Since the initial plans called for earlier introductions
and since there have been significant changes in the market environment since
the Company entered into the joint venture, there is reason to believe that any
products that may be marketed in the
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<PAGE>
future could represent significantly poorer financial opportunities than those
that were anticipated in the earlier plans. This reduction in opportunity
derives from factors such as the presence of direct competitors to Genta Jago's
products being in the marketplace before Genta Jago, and increasing pricing
pressures on pharmaceuticals, particularly multisource or generic products from
payers such as reimbursers and government buyers. See "MD&A--Certain Trends and
Uncertainties--Uncertainty of Technological Change and Competition" and
"MD&A--Certain Trends and Uncertainties--Uncertainty of Product Pricing,
Reimbursement and Related Matters." Both of these factors may adversely affect
Genta Jago even if it is successful in developing products to obtain regulatory
approval. As a result and in consideration of the Company's need to reduce
expenses and focus its efforts, the Company is seeking to direct its resources
from the joint venture to its Anticode development, specifically G3139, for the
immediate future.
Interest income has fluctuated significantly each year and is
anticipated to continue to fluctuate primarily due to changes in the levels of
cash, investments and interest rates each period.
Interest expense was $3,323,000 in 1997, $886,000 in 1996, and $323,000
in 1995. In consideration of EITF D-60 which was issued by the SEC in March
1997, the Company recorded $666,667 in imputed interest on $2.0 million in 4%
Convertible Debentures due August 1, 1997, that were originally issued in
September 1996 and were converted at a 25% discount to market. The discount
represents an effective interest rate of 38%. The charge has been included in
Interest expense in 1996. The Company also recorded a $3.0 million charge to
imputed interest in 1997 related to value associated with 6.4 million Bridge
Warrants issued in connection with a $ 3.0 million debt issue in February 1997.
In April 1998, in consideration of EITF D-60, the Company recorded
$2,348,000 and $1,000,000 in imputed dividends in 1996 and 1995, respectively,
for discounted conversion terms related to convertible preferred stock issued in
1996 and 1995. The preferred stock was convertible into common shares based on a
conversion price equal to 75% of the average closing bid prices of the Company's
common stock for a specified period. In 1997, the Company recorded $16,158,000
in imputed dividends for discounted conversion terms and liquidation preference
of the Series D Preferred Stock issued in the Private Placement. The charges
have been recorded as dividends imputed on preferred stock.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, the Company has financed its operations primarily from
private and public offerings of its equity securities. Cash provided from these
offerings totaled approximately $112.4 million through December 31, 1997,
including net proceeds of $17.0 million raised during 1997. At December 31,
1997, the Company had cash, cash
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equivalents and short-term investments totaling $8.5 million compared to
$532,000 at December 31, 1996. The increase in cash, cash equivalents and
short-term investments during 1997 is largely attributable to proceeds from the
Company's private placements, as described in Note 8 to the Company's
consolidated financial statements.
The Company will need substantial additional funds before it can expect
to realize significant product revenue. The Company projects that at its current
rate of spending and for its current activities, its existing cash funds will
enable the Company to maintain its present operations into the first quarter of
1999. To the extent that the Company is successful in accelerating its
development of G3139 or in expanding its development portfolio or acquiring or
adding new development candidates, the current cash resources would be consumed
at a greater rate. Similarly, the Company has been seeking to identify and hire
additional senior managers to direct the business of the Company. To the extent
it is successful in these endeavors, the rate of cash utilization would also
increase. Certain parties with whom the Company has agreements have claimed
default and, should the Company be obligated to pay these claims or should the
Company engage legal services to defend or negotiate its positions or both, its
ability to continue operations could be significantly reduced or shortened. See
"MD&A--Certain Trends and Uncertainties--Claims of Genta's Default Under Various
Agreements." The Company anticipates that significant additional sources of
financing, including equity financings, will be required in order for the
Company to continue its planned principal operations. The Company also
anticipates seeking additional product development opportunities from external
sources. Such acquisitions may consume cash reserves or require additional cash
or equity. The Company's working capital and additional funding requirements
will depend upon numerous factors, including: (i) the progress of the Company's
research and development programs; (ii) the timing and results of preclinical
testing and clinical trials; (iii) the level of resources devoted to Genta Jago;
(iv) the level of resources that the Company devotes to sales and marketing
capabilities; (v) technological advances; (vi) the activities of competitors;
and (vii) the ability of the Company to establish and maintain collaborative
arrangements with others to fund certain research and development efforts, Jto
conduct clinical trials, to obtain regulatory approvals and, if such approvals
are obtained, to manufacture and market products. See "MD&A--Certain Trends and
Uncertainties--Need for Additional Funds; Risk of Insolvency."
If the Company successfully secures sufficient levels of collaborative
revenues and other sources of financing, it expects to use such financing to
continue and expand its ongoing research and development activities, preclinical
testing and clinical trials, manufacturing activities, costs associated with the
market introduction of potential products, expansion of its administrative
activities.
In connection with the Genta Jago joint venture formed in late 1992 and
expanded in May 1995, the Company provides funding to Genta Jago pursuant to a
working capital
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loan agreement that expires in October 1998. The loans are advanced up to a
mutually agreed upon maximum commitment amount, which amount is established by
Genta and Genta Jago not less than once each calendar quarter, if necessary,
based upon the review and consideration by the parties of mutually-acceptable
budgets, expense reports, forecasts and workplans for research and development
of the products by Genta Jago. Genta is not required to fund amounts in excess
of the agreed-upon commitment amount. Working capital loans consist of cash
advances to Genta Jago from Genta and research expenses incurred by Genta on
behalf of Genta Jago. Such working capital loans to Genta Jago are recorded by
Genta as Loans receivable from joint venture and are expensed on Genta's books
as funds are spent by Genta Jago, as the collectibility of such loans is no
longer assured. In connection with Genta Jago's return of the Anticode(TM)
oligonucleotide license rights to Genta in May 1995, the working capital loan
payable by Genta Jago to Genta was credited with a principal and interest
reduction of approximately $4.7 million. As of December 31, 1997, the Company
had advanced working capital loans of approximately $15.8 million to Genta Jago,
net of principal repayments and the aforementioned credit, which amount fully
satisfied what the Company believes is the loan commitment established by the
parties through December 31, 1997. Such loans bear interest at rates per annum
ranging from 5.81% to 7.5%, and are payable in full on October 20, 1998, or
earlier in the event certain revenues are received by Genta Jago and specified
cash balances are maintained by Genta Jago. There can be no assurance, however,
that Genta Jago will obtain sufficient financial resources to repay such loans
to Genta. Genta Jago repaid Genta $1 million in principal of its working capital
loans, in November 1996, from license fee revenues. The amount of future loans
by Genta to Genta Jago will depend upon several factors, including the amount of
funding obtained by Genta Jago through collaborative arrangements, Genta's
ability and willingness to provide loans, and the timing and cost of Genta
Jago's preclinical studies, clinical trials and regulatory activities. The
Company is currently in negotiations with Jagotec and its affiliates to reach an
agreement under which the terms of the joint venture would be restructured.
There can be no assurance that such negotiations will result in a mutually
satisfactory agreement. See "MD&A-- Certain Trends and Uncertainties--Claims of
Genta's Default Under Various Agreements."
In 1997, the Company did not acquire additional property or equipment.
Through December 31, 1997, the Company acquired $10.1 million in property and
equipment of which $5.5 million was financed through capital leases and other
equipment financing arrangements, $3.3 million was funded in cash and the
remainder was acquired through the Company's acquisition of JBL. The Company has
commitments associated with its capital leases and operating leases as discussed
further in Note 7 to the Company's consolidated financial statements. In 1997,
the Company bought out its equipment finance loan balance with the $251,000 in
security deposits then held by the equipment finance company. During 1997, fixed
assets decreased due to the sale of furniture and equipment incident to the
reduction of operations at Genta Pharmaceuticals Europe and the closure of the
research and development laboratory at Genta's San Diego facility. Leasehold
improvements were written off by approximately $353,000 to General and
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Administrative expense due to the reduction of operations at Genta
Pharmaceuticals Europe. The Company discontinued its effort to develop a
capability at JBL to manufacture oligonucluotides and wrote off $530,000 to
research and development expense.
In October 1996, JBL retained a chemical consulting firm to advise it
with respect to an incident of soil and groundwater contamination. See
"MD&A--Certain Trends and Uncertainties--No Assurance of Regulatory Approval;
Government Regulation." The Company believes that any costs associated with
further investigating or remediating this contamination will not have a material
adverse effect on the business of the Company, although there can be no
assurance thereof.
Terms of the Company's Series A Preferred Stock require the payment of
dividends annually in amounts ranging from $3 per share per annum for the first
year to $5 per share per annum in the third and fourth years. Dividends may be
paid in cash or common stock or a combination thereof, at the Company's option.
Dividends on the Series A Preferred Stock accrue on a daily basis (whether or
not declared) and shall accumulate to the extent not paid on the annual dividend
payment date following the dividend period for which they accrue. The Company
may redeem the Series A Preferred Stock under certain circumstances, and was
required to redeem the Series A Preferred Stock, subject to certain conditions,
in September 1996 at a redemption price of $50 per share, plus accrued and
unpaid dividends (the "Redemption Price"). The Company elected to pay the
Redemption Price in Common Stock in order to conserve cash and was required
under the terms of the Series A Preferred Stock to use its best efforts to
arrange for a firm commitment underwriting for the resale of such Common Stock
which would allow the holders ultimately to receive cash instead of securities
for their Series A Preferred Stock. Despite using its best efforts, the Company
was unable to arrange for a firm commitment underwriting. Therefore, under the
terms of the Series A Preferred Stock, Genta was not required to redeem such
Series A Preferred Stock in cash, but rather was required to redeem all shares
of Series A Preferred Stock held by holders who elected to waive the firm
commitment underwriting requirement and receive the redemption price in shares
of Common Stock. A waiver of the firm commitment underwriting was included as a
condition of such redemption. The terms of the Series A Preferred Stock do not
impose adverse consequences on the Company if it is unable to arrange for such
an underwriting despite its reasonable efforts in such regard. In September
1996, holders of 55,900 shares of Series A Preferred Stock redeemed such shares
and related accrued and unpaid dividends for an aggregate of 242,350 shares of
the Company's Common Stock. The effect on the financial statements of the
redemptions was a reduction in Accrued dividends on preferred stock, a reduction
in the Par value of convertible preferred stock, an increase in the Par value of
Common Stock, and an increase in Additional paid-in capital. Should the
remaining shares of Series A Preferred stock be redeemed for, or converted into,
the Company's Common Stock, the effect on the financial statements will be the
same as that previously
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described. The Company is restricted from paying cash dividends on Common Stock
until such time as all cumulative dividends on outstanding shares of Series A
and Series D Preferred Stock have been paid. The Company currently intends to
retain its earnings, if any, after payment of dividends on outstanding shares of
Series A and Series D Preferred Stock, for the development of its business. See
"MD&A--Certain Trends and Uncertainties--Subordination of Common Stock to Series
A and Series D Preferred Stock; Risk of Dilution; Anti-Dilution Adjustments."
The Company continually evaluates its intangible assets for impairment.
If evidence of impairment is noted, the Company determines the amount of
impairment and charges such impairment to expense in the period that impairment
is determined. Through December 31, 1997 management has considered projected
future cash flows from product sales, collaborations and proceeds on sale of
such assets and, other than the $600,000 charge recorded in 1997 related to the
disposal of certain patents, has determined that no additional impairment
exists. See "MD&A--Results of Operations."
IMPACT OF YEAR 2000
Some older computer programs were written using two digits rather than
four to define the applicable year. As a result, those computer programs have
time sensitive software that recognizes a date using 00 as the year 1900 rather
than the year 2000 (the "Year 2000 Issue"). This could cause a system failure or
miscalculations causing disruption of operations, including a temporary
inability to process transactions or engage in similar normal business
activities.
The Company is completing an assessment of whether it will have to
modify or replace portions of its software so that its computer systems will
function properly with respect to dates in the year 2000 and thereafter. The
total year 2000 project cost is not expected to be material. The year 2000
project is expected to be completed not later than December 31, 1998, which is
prior to any anticipated impact on its operating systems. The Company believes
that with modifications to existing software and conversions to new software,
the Year 2000 Issue will not pose significant operational problems for its
computer systems. However, if such modifications and conversions are not made,
or are not completed timely, the Year 2000 Issue could have a material adverse
effect on the operations of the Company.
The Company has initiated formal communications with all of its
significant suppliers to determine the extent to which the Company's interface
systems are vulnerable to those third parties' failure to remediate their own
Year 2000 Issues. There is no assurance that the systems of other companies on
which the Company's systems rely will be timely converted and will not have a
material adverse effect on the Company's systems. The costs of the project and
the date on which the Company believes it will complete the year 2000
modifications are based on management's best
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estimates, which were derived using numerous assumptions of future events,
including the continued availability of certain resources and other factors.
However, there can be no assurance that these estimates will be achieved and
actual results could differ materially from those anticipated. Specific factors
that might cause such material differences include, but are not limited to, the
availability and cost of personnel trained in this area, the ability to locate
and correct all relevant computer codes, and similar uncertainties.
CERTAIN TRENDS AND UNCERTAINTIES
In addition to the other information contained in this Annual Report on
Form 10-K/A, the following factors should be considered carefully.
Need for Additional Funds; Risk of Insolvency.
Genta's operations to date have consumed substantial amounts of cash.
The Company's auditors have included an explanatory paragraph in their opinion
with respect to the Company's ability to continue as a going concern. See
"Report of Ernst & Young, LLP, Independent Auditors" and "MD&A--Liquidity and
Capital Resources." The Company will need to raise substantial additional funds
to conduct the costly and time-consuming research, pre-clinical development and
clinical trials necessary to bring its products to market and to establish
production and marketing capabilities. The Company intends to seek additional
funding through public or private financings, including equity financings, and
through collaborative arrangements. Adequate funds for these purposes, whether
obtained through financial markets or collaborative or other arrangements with
corporate partners or from other sources, may not be available when needed or on
terms acceptable to the Company. Insufficient funds may require the Company: to
delay, scale back or eliminate some or all of its research and product
development programs; to license third parties to commercialize products or
technologies that the Company would otherwise seek to develop itself; to sell
itself to a third party; to cease operations; or to declare bankruptcy. The
Company's future cash requirements will be affected by results of research and
development, results of pre-clinical studies and bioequivalence and clinical
trials, relationships with corporate collaborators, changes in the focus and
direction of the Company's research and development programs, competitive and
technological advances, resources devoted to Genta Jago, the FDA and foreign
regulatory processes, potential litigation by companies seeking to prevent or
delay marketing approval of Genta Jago's products and other factors.
Loss History; Uncertainty of Future Profitability.
Genta has been unprofitable to date, incurring substantial operating
losses associated with ongoing research and development activities, pre-clinical
testing, clinical trials, manufacturing activities and development activities
undertaken by Genta Jago.
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From the period since its inception to December 31, 1997, the Company has
incurred a cumulative net loss of $124.5 million. The Company has experienced
significant quarterly fluctuations in operating results and expects that these
fluctuations in revenues, expenses and losses will continue. The Company's
independent auditors have included an explanatory paragraph in their report to
the Company's financial statements at December 31, 1997, which paragraph
expresses substantial doubt as to the Company's ability to continue as a going
concern. See "Report of Ernst & Young LLP, Independent Auditors" and
"MD&A--Certain Trends and Uncertainties--Need for Additional Funds; Risk of
Insolvency."
Subordination of Common Stock to Series A and Series D Preferred Stock; Risk of
Dilution; Anti-Dilution Adjustments.
In the event of the liquidation, dissolution or winding up of the
Company, the Common Stock is expressly subordinate to the approximately $27.2
million preference of the 453,100 outstanding shares of Series A Preferred Stock
and the approximately $37.4 million preference of 267,390 shares of Series D
Preferred Stock (including 40,395 shares of Series D Preferred Stock issuable
upon exercise of certain warrants). Dividends may not be paid on the Common
Stock unless full cumulative dividends on the Series A and Series D Preferred
Stocks have been paid or funds have been set aside for such preferred dividends
by the Company.
The conversion rate of the Series A Preferred Stock and the exercise
price of warrants issued in connection with the Series A Preferred Stock (the
"Series A Warrants") are subject to adjustment, among other things, upon certain
issuances of Common Stock or securities convertible into Common Stock at $67.50
per share or less. As of March 1, 1998, each share of Series A Preferred Stock
is convertible into approximately 7.25 shares of Common Stock at a conversion
price of $8.27 per share and the exercise price of the Series A Warrants is
presently $9.32 per share. There are outstanding Series A Warrants to purchase
an aggregate of 675,966 shares of Common Stock, which expire on September 24,
1998. The conversion rate of the Series D Preferred Stock and the exercise
prices of the Class D Warrants are subject to adjustment, among other things,
upon certain issuances of Common Stock or securities convertible into Common
Stock at prices per share below certain levels. In addition, the Conversion
Price of the Series D Preferred Stock in effect on June 29, 1998 (the "Reset
Date") will be adjusted and reset effective as of the Reset Date if the average
closing bid price of the Common Stock for the 20 consecutive trading days
immediately preceding the Reset Date (the "12 Month Trading Price") is less than
140% of the then applicable Conversion Price (a "Reset Event"). Upon the
occurrence of a Reset Event, the then applicable Conversion Price will be
reduced to be equal to the greater of (i) the 12 Month Trading Price divided by
1.40 and (ii) 25% of the then applicable Conversion Price. Each share of Series
D Preferred Stock is presently convertible into approximately 106 shares of
Common Stock, at a conversion price of $0.94375 per share
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of Common Stock, and the exercise price of the Class D Warrants is presently
$0.94375 per share. There are 807,900 Class D Warrants outstanding and another
201,975 Class D Warrants issuable upon the exercise of certain warrants.
Finally, the Company has outstanding Bridge Warrants to purchase an aggregate of
6,357,616 shares of Common Stock at an exercise price of $0.471875 per share,
Line of Credit Warrants to purchase an aggregate of 50,000 shares of Common
Stock at an exercise price of $2.50 per share, warrants to purchase an aggregate
of 95,768 shares of Common Stock at various exercise prices between
approximately $13 and $21 per share and outstanding employee stock options. The
Note and Warrant Purchase Agreement provides that a number of additional Bridge
Warrants ("Penalty Warrants") equal to 1.5% of the number of Bridge Warrants
then held by the Aries Funds shall be issued to the Aries Funds for each day
beyond 30 days after the final closing of the Private Placement that a shelf
registration statement covering the Common Stock underlying the securities
purchased pursuant to the Note and Warrant Purchase Agreement is not filed with
the SEC and for each day beyond 210 days after the closing date of the
investment contemplated by the Note and Warrant Purchase Agreement that such
shelf registration statement is not declared effective by the SEC. The Company
filed such shelf registration statement with the SEC on September 9, 1997,
however, the Company has to date been unable to have such shelf registration
statement declared effective by the SEC. As a result, the Company could be
obligated to issue Penalty Warrants to the Aries Funds. The Aries Funds have
not, to date, requested that the Company issue such Penalty Warrants. The
Company and the Aries Funds are currently conducting negotiations to determine
whether, and to what extent, Penalty Warrants will be issued. See "Market for
Registrant's Common Equity and Related Stockholder Matters--Recent Sales of
Unregistered Securities."
Claims of Genta's Default Under Various Agreements.
On May 7, 1997 Jago and Jagotec gave Genta Jago formal notices of its
assertion that Genta Jago is in breach of the Restated GEOMATRIX(R) Services
Agreement, the Restated GEOMATRIX(R) Research and Development Agreement and the
Restated GEOMATRIX(R) License Agreement, stating that should the breach not be
cured within the applicable cure period, Genta Jago would reserve the right to
terminate the agreements in accordance with their terms. Each of these
Agreements provides for a cure period of 30 days, except that if the default is
not capable of being cured within this period and the defaulting party is
diligently undertaking to cure such default as soon as commercially feasible
thereafter under the circumstances, then the non-breaching party shall have no
right to terminate the agreement. In addition each of these agreements contains
a provision providing for the final resolution of any disputes, claims or
controversies, whether before or after termination of the agreement, by
arbitration in Paris, France. After the 30-day cure period expired, Jago did not
take action purporting to terminate these agreements but did not rescind the
notices of default. Jago, Jagotec and Jago Holding AG also gave formal notice of
default under the Restated Joint Venture and Shareholders Agreement, contending
that due to Genta's failure to meet its funding
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obligations to Genta Jago, Genta Jago was unable to fulfill its obligations to
Jago. The amount claimed by Jago to be in default is approximately $1.2 million,
of which $200,000 relates to 1997 and $1.0 million relates to development costs
and license fees for 1996. There is no specific cure period contained in the
Restated Joint Venture and Shareholders Agreement but rather a provision
providing for resolution of disputes, claims or controversies by arbitration in
Paris, France. The Company recently met with Jago and is attempting to resolve
the situation without resort to arbitration. While a termination of these
agreements may have a material adverse effect on the Company, the Company
intends to oppose vigorously Jago's position. Stating that it was without
prejudice to Genta's position, Genta provided approximately $129,000 to Genta
Jago for the payment by Genta Jago of all amounts claimed by Jago under the
Restated GEOMATRIX(R) License Agreement and certain other amounts owed by Genta
Jago to third parties (both included in Jago's notice of default). On May 15,
1997, Johns Hopkins sent Genta a letter stating that the Johns Hopkins Agreement
was terminated. On November 26, 1997 the Ts'o/Miller Partnership sent Genta a
letter claiming that Genta was in material breach of the Ts'o/Miller Agreement
for failing to pay royalties from 1995 through 1997. This notice further advised
that if the alleged breach were not cured within 90 days of the notice the
license would be terminated. See "Business--Anticode(TM) Brand of Antisense
Oligonucleotide Programs--Oligonucleotide Collaborative and Licensing
Agreements--Ts'o/Miller/Hopkins." The French government agency L'Agence
Nationale de Valorisation de la Recherche (ANVAR) asserted, in a letter dated
February 13, 1998, that Genta Europe was not in compliance with the ANVAR
Agreement, and that ANVAR might request the immediate repayment of such loan.
The Company does not believe that under the terms of the ANVAR Agreement, ANVAR
is entitled to request early repayment and is working with ANVAR to achieve a
mutually satisfactory resolution. See "Business--Genta Europe." LBC Capital
Resources, Inc. ("LBC"), a Philadelphia-based broker/dealer, has asserted claims
against the Company and others. See "Legal Proceedings." There can be no
assurance that the Company will not incur material costs in relation to these
terminations and/or assertions of default or liability. See "MD&A--Liquidity and
Capital Resources."
Early Stage of Development; Technological Uncertainty.
Genta is at an early stage of development. All of the Company's
potential therapeutic products are in research or development, and no revenues
have been generated from therapeutic product sales. To date, most of the
Company's resources have been dedicated to applying molecular biology and
medicinal chemistry to the research and development of potential Anticode(TM)
pharmaceutical products based upon oligonucleotide technology. While the Company
has demonstrated the activity of Anticode(TM) oligonucleotide technology in
model systems in vitro and the activity of antisense technology in animals and
has identified compounds that the Company believes are worthy of additional
testing, only one of these potential Anticode(TM) oligonucleotide products has
begun to be tested in humans, with such testing in its early stages. There
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can be no assurance that the novel approach of oligonucleotide technology will
result in products that will receive necessary regulatory approvals or that will
be successful commercially. Further, results obtained in pre-clinical studies or
early clinical investigations or pilot bioequivalence trials are not necessarily
indicative of results that will be obtained in pivotal human clinical or
bioequivalence trials. There can be no assurance that any of the Company's or
Genta Jago's potential products can be successfully developed. Furthermore, the
Company's products in research or development may prove to have undesirable and
unintended side effects or other characteristics that may prevent or limit their
commercial use. There can be no assurance that the Company will be permitted to
undertake human clinical testing of the Company's products currently in
pre-clinical development, or, if permitted, that such products will be
demonstrated to be safe and efficacious. The Company is pursuing research and
development through Genta Jago of a range of oral controlled-release
formulations of currently available pharmaceuticals. Many of the products to be
developed through Genta Jago have not yet been formulated using GEOMATRIX
technology. In addition, none of the products being developed through Genta Jago
has had its manufacturing process successfully scaled-up for commercial
production or has started pivotal bioequivalence trials. In addition, there can
be no assurance that any of the Company's or Genta Jago's products will obtain
FDA or foreign regulatory approval for any indication or that an approved
compound would be capable of being produced in commercial quantities at
reasonable costs and successfully marketed. Products, if any, resulting from
Genta's or Genta Jago's research and development programs are not expected to be
commercially available for a number of years. Certain competitive products have
already been filed with and/or approved by the FDA. See "MD&A--Certain Trends
and Uncertainties--Potential Adverse Effect of Technological Change and
Competition."
Limited Availability of Net Operating Loss Carry Forwards.
At December 31, 1997, the Company has federal and California net
operating loss carryforwards of approximately $71,697,000 and $15,236,000,
respectively. The difference between the federal and California tax loss
carryforwards is primarily attributable to the capitalization of research and
development expenses for California tax purposes and the fifty percent
limitation on California loss carryforwards prior to 1997. The federal tax loss
carryforwards will begin expiring in 2003, unless previously utilized.
Approximately $2,767,000 of the California tax loss carryforward expired during
1997 and the related deferred tax asset and tax loss carryforward amounts have
been reduced accordingly. The remaining California tax loss will continue to
expire in 1998, unless utilized. The Company also has federal and California
research and development tax credit carryforwards of $2,921,000 and $1,203,000,
respectively, which will begin expiring in 2003 unless previously utilized.
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Federal and California tax laws limit the utilization of income tax net
operating loss and credit carryforwards that arise prior to certain cumulative
changes in a corporation's ownership resulting in change of control of the
Company. The future annual use of net operating loss carryforwards and research
and development tax credits will be limited due to the ownership changes that
occurred during 1990, 1991, 1993, 1996 and 1997. Because of the decrease in
value of the Company's stock, the ownership changes which occurred in 1996 and
1997, will have a material adverse impact on the Company's ability to utilize
these carryforwards. See "Market for Registrant's Common Equity and Related
Stockholder Matters--Recent Sales of Unregistered Securities."
Dividends.
The Company has never paid cash dividends on its Common Stock and does
not anticipate paying any such dividends in the foreseeable future. In addition,
the Company is restricted from paying cash dividends on its Common Stock until
such time as all cumulative dividends have been paid on outstanding shares of
its Series A and Series D Preferred Stocks. The Company currently intends to
retain its earnings, if any, after payment of dividends on outstanding shares of
Series A and Series D Preferred Stocks, for the development of its business. See
"MD&A--Liquidity and Capital Resources."
No Assurance of Regulatory Approval; Government Regulation.
The FDA and comparable agencies in foreign countries impose substantial
premarket approval requirements on the introduction of pharmaceutical products
through lengthy and detailed pre-clinical and clinical testing procedures and
other costly and time-consuming procedures. Satisfaction of these requirements,
which includes demonstrating to the satisfaction of the FDA and foreign
regulatory agencies that the product is both safe and effective, typically takes
several years or more depending upon the type, complexity and novelty of the
product. There can be no assurance that such testing will show any product to be
safe or efficacious or, in the case of certain of Genta Jago's products, to be
bioequivalent to a currently marketed pharmaceutical. Government regulation also
affects the manufacture and marketing of pharmaceutical products. The effect of
government regulation may be to delay marketing of any new products for a
considerable or indefinite period of time, to impose costly procedures upon the
Company's or Genta Jago's activities and to diminish any competitive advantage
that the Company or Genta Jago may have attained. It may take years before
marketing approvals are obtained for the Company's or Genta Jago's products, if
at all. There can be no assurance that FDA or other regulatory approval for any
products developed by the Company or Genta Jago will be granted on a timely
basis, if at all, or, if granted, that such approval will cover all the clinical
indications for which the Company or Genta Jago is seeking approval or will not
sustain significant limitations in the form of warnings, precautions or
contraindications with respect to conditions of use. Further, with respect to
the reformulated versions of currently available pharmaceuticals being
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developed through Genta Jago, there is a substantial risk that the manufacturers
or marketers of such currently available pharmaceuticals will seek to delay or
block regulatory approval of any reformulated versions of such pharmaceuticals
through litigation or other means. Any significant delay in obtaining, or
failure to obtain, such approvals could materially adversely affect the
Company's or Genta Jago's revenue. Moreover, additional government regulation
from future legislation or administrative action may be established which could
prevent or delay regulatory approval of the Company's or Genta Jago's products
or further regulate the prices at which the Company's or Genta Jago's proposed
products may be sold.
The Company is also subject to various foreign, federal, state and
local laws, regulations and recommendations (collectively "Governmental
Regulations") relating to safe working conditions, laboratory and manufacturing
practices, the experimental use of animals and the use, manufacture, storage,
handling and disposal of hazardous or potentially hazardous substances,
including radioactive compounds and infectious disease agents, used in
connection with the Company's research and development work and manufacturing
processes. In October 1996, JBL retained a chemical consulting firm to advise it
with respect to an incident of soil and groundwater contamination (the "Spill").
Sampling conducted at the JBL facility revealed the presence of chloroform and
perchloroethylenes ("PCEs") in the soil and groundwater at this site. Six soil
borings were drilled and groundwater wells were installed at several locations
around the site. Chloroform was detected at levels of up to 190 ug/liter
on-site, exceeding the California Drinking Water Maximum Contamination Level for
trihalomethanes of 100 ug/liter. PCEs were also detected at levels of up to 22
ug/liter on-site, exceeding the California Drinking Water Maximum Contamination
Level of 5 ug/liter. In addition, Toluene was detected at levels of up to 2
ug/liter at several points on-site, which is significantly below the California
Toxicity Action Level of 100 ug/liter. These toxicity levels are not binding, as
the final regulatory maximum levels may be higher or lower. JBL has notified the
appropriate regulatory agency, the California Regional Water Quality Control
Board, of conditions at the site, and with the agency's approval, JBL is
monitoring groundwater conditions at the site on a quarterly basis. JBL is
currently in the pre-regulatory action stage with ongoing site monitoring and
site assessment. In addition, current sampling results indicate that
contaminants may be migrating off-site. An off-site well, used as a domestic and
irrigation water source, has shown evidence of being impacted by chloroform at
0.9 ug/liter, significantly below (less than one percent of) the California
Drinking Water Maximum Contamination Level for trihalomethanes of 100 ug/liter,
and toluene at 0.9 ug/liter, also significantly below (less than one percent of)
the California Toxicity Action Level of 100 ug/liter. While another off-site
well has been found to contain chloroform, the engineering consultant concluded
that the contaminants do not appear to relate to impact from the JBL site. The
Company believes that any costs associated with further investigating or
remediating this contamination will not have a material adverse effect on the
business of the Company, although there can be no assurance thereof. The Company
believes that it is in material compliance with
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Governmental Regulations, however there can be no assurance that the Company
will not be required to incur significant costs to comply with Governmental
Regulations in the future.
Uncertainty Regarding Patents and Proprietary Technology.
The Company's and Genta Jago's success will depend, in part, on their
respective abilities to obtain patents, maintain trade secrets and operate
without infringing the proprietary rights of others. No assurance can be given
that patents issued to or licensed by the Company or Genta Jago will not be
challenged, invalidated or circumvented, or that the rights granted thereunder
will provide competitive advantages to the Company or Genta Jago. There can be
no assurance that the Company's or Genta Jago's patent applications will be
approved, that the Company or Genta Jago will develop additional products that
are patentable, that any issued patent will provide the Company or Genta Jago
with any competitive advantage or adequate protection for its inventions or will
not be challenged by others, or that the patents of others will not have an
adverse effect on the ability of the Company or Genta Jago to do business.
Competitors may have filed applications, may have been issued patents or may
obtain additional patents and proprietary rights relating to products or
processes competitive with those of the Company or Genta Jago. Furthermore,
there can be no assurance that others will not independently develop similar
products, duplicate any of the Company's or Genta Jago's products or design
around any patented products developed by the Company or Genta Jago. The Company
and Genta Jago rely on secrecy to protect technology in addition to patent
protection, especially where patent protection is not believed to be appropriate
or obtainable. No assurance can be given that others will not independently
develop substantially equivalent proprietary information and techniques or
otherwise gain access to the Company's or Genta Jago's trade secrets, or that
the Company or Genta Jago can effectively protect its rights to its unpatented
trade secrets.
Genta and Genta Jago have obtained licenses or other rights to patents
and other proprietary rights of third parties, and may be required to obtain
licenses to additional patents or other proprietary rights of third parties. No
assurance can be given that any existing licenses and other rights will remain
in effect or that any licenses required under any such additional patents or
proprietary rights would be made available on terms acceptable to the Company or
Genta Jago, if at all. If Genta's or Genta Jago's licenses and other rights are
terminated or if Genta or Genta Jago cannot obtain such additional licenses,
Genta or Genta Jago could encounter delays in product market introductions while
it attempts to design around such patents or could find that the development,
manufacture or sale of products requiring such licenses could be foreclosed. In
addition, the Company or Genta Jago could incur substantial costs, including
costs caused by delays in obtaining regulatory approval and bringing products to
market, in defending itself in any suits brought against the Company or Genta
Jago claiming infringement of the patent rights of third parties or in asserting
the Company's or Genta Jago's patent
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rights, including those granted by third parties, in a suit against another
party. The Company or Genta Jago may also become involved in interference
proceedings declared by the United States Patent and Trademark Office (or any
foreign counterpart) in connection with one or more of its patents or patent
applications, which could result in substantial cost to the Company or Genta
Jago, as well as an adverse decision as to priority of invention of the patent
or patent application involved. There can be no assurance that the Company or
Genta Jago will have sufficient funds to obtain, maintain or enforce patents on
their respective products or technology, to obtain or maintain licenses that may
be required in order to develop and commercialize their respective products, to
contest patents obtained by third parties, or to defend against suits brought by
third parties.
Dependence on Others.
The Company's and Genta Jago's strategy for the research, development
and commercialization of their products requires negotiating, entering into and
maintaining various arrangements with corporate collaborators, licensors,
licensees and others, and is dependent upon the subsequent success of these
outside parties in performing their responsibilities. No assurance can be given
that they will obtain such collaborative arrangements on acceptable terms, if at
all, nor can any assurance be given that any current collaborative arrangements
will be maintained.
Technology Licensed From Third Parties.
The Company has entered into certain agreements with, and licensed
certain technology and compounds from, third parties. The Company has relied on
scientific, technical, clinical, commercial and other data supplied and
disclosed by others in entering into these agreements, including the Genta Jago
agreements, and will rely on such data in support of development of certain
products. Although the Company has no reason to believe that this information
contains errors of omission or fact, there can be no assurance that there are no
errors of omission or fact that would materially affect the future approvability
or commercial viability of these products.
Potential Adverse Effect of Technological Change and Competition.
The biotechnology industry is subject to intense competition and rapid
and significant technological change. The Company and Genta Jago have numerous
competitors in the United States and other countries for their respective
technologies and products under development, including among others, major
pharmaceutical and chemical companies, specialized biotechnology firms,
universities and other research institutions. There can be no assurance that the
Company's or Genta Jago's competitors will not succeed in developing products or
other novel technologies that are more effective than any which have been or are
being developed by the Company or Genta Jago or which
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would render the Company's or Genta Jago's technology and products
non-competitive. Many of the Company's and Genta Jago's competitors have
substantially greater financial, technical, marketing and human resources than
the Company or Genta Jago. In addition, many of those competitors have
significantly greater experience than the Company or Genta Jago in undertaking
pre-clinical testing and human clinical trials of new pharmaceutical products
and obtaining FDA and other regulatory approvals of products for use in
healthcare. Accordingly, the Company's or Genta Jago's competitors may succeed
in obtaining regulatory approval for products more rapidly than the Company or
Genta Jago and such competitors may succeed in delaying or blocking regulatory
approvals of the Company's or Genta Jago's products. As competitors of the
Company or of Genta Jago receive approval to products that share the same
potential market as the Company's or Genta Jago's potential products, the market
share available to the Company or Genta Jago will likely be reduced, thereby
reducing the potential revenues and earnings available to the Company or Genta
Jago. In addition, increased pricing competition would also likely result,
further reducing the earnings potential of Company's or Genta Jago's products.
In December 1997, a competitor of the Company, Elan Corporation, received
approval of their ANDA for a generic formulation of Oruvail(R) (ketoprofen), and
another company, Mylan Laboratories, Inc., has filed an ANDA for a generic
formulation of Procardia XL(R) (nifedipine). Furthermore, if the Company or
Genta Jago is permitted to commence commercial sales of products, it will also
be competing with respect to marketing capabilities, an area in which it has
limited or no experience, and manufacturing efficiency. There are many public
and private companies that are conducting research and development activities
based on drug delivery or antisense technologies. The Company believes that the
industry-wide interest in such technologies will accelerate and competition will
intensify as the techniques which permit drug design and development based on
such technologies are more widely understood.
Uncertainty of Clinical Trials and Results.
The results of clinical trials and pre-clinical testing are subject to
varying interpretations. Even if the development of the Company's or Genta
Jago's respective products advances to the clinical stage, there can be no
assurance that such products will prove to be safe and effective. The products
that are successfully developed, if any, will be subject to requisite regulatory
approval prior to their commercial sale, and the approval, if obtainable, may
take several years. Generally, only a very small percentage of the number of new
pharmaceutical products initially developed is approved for sale. Even if
products are approved for sale, there can be no assurance that they will be
commercially successful. The Company or Genta Jago may encounter unanticipated
problems relating to development, manufacturing, distribution and marketing,
some of which may be beyond the Company's or Genta Jago's respective financial
and technical capacity to solve. The failure to address such problems adequately
could have a material adverse effect on the Company's or Genta Jago's respective
businesses, financial conditions, prospects and results of operations. No
assurance can be given that the
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Company or Genta Jago will succeed in the development and marketing of any new
drug products, or that they will not be rendered obsolete by products of
competitors. "See "MD&A--Certain Trends and Uncertainties-- Potential Adverse
Effect of Technological Change and Competition."
Difficult Manufacturing Process; Access to Certain Raw Materials.
The manufacture of Anticode(TM) oligonucleotides is a time-consuming
and complex process. Management believes that the Company has the ability to
acquire or produce quantities of oligonucleotides sufficient to support its
present needs for research and its projected needs for its initial clinical
development programs. However, in order to obtain oligonucleotides sufficient to
meet the volume and cost requirements needed for certain commercial applications
of Anticode(TM) oligonucleotide products, Genta requires raw materials currently
provided by a single supplier which is itself a development stage biotechnology
company (and a competitor of the Company) and is subject to uncertainties
including the potential for a decision by such supplier to discontinue
production of such raw materials, the insolvency of such supplier, or the
failure of such supplier to follow applicable regulatory guidelines. Products
based on chemically modified oligonucleotides have never been manufactured on a
commercial scale. The manufacture of all of the Company's and Genta Jago's
products will be subject to current GMP requirements prescribed by the FDA or
other standards prescribed by the appropriate regulatory agency in the country
of use. There can be no assurance that the Company or Genta Jago will be able to
manufacture products, or have products manufactured for it, in a timely fashion
at acceptable quality and prices, that they or third party manufacturers can
comply with GMP or that they or third party manufacturers will be able to
manufacture an adequate supply of product.
Limited Sales, Marketing and Distribution Experience.
The Company and Genta Jago have very limited experience in
pharmaceutical sales, marketing and distribution. In order to market and sell
certain products directly, the Company or Genta Jago would have to develop or
subcontract a sales force and a marketing group with technical expertise. There
can be no assurance that any direct sales or marketing efforts would be
successful.
Uncertainty of Product Pricing, Reimbursement and Related Matters.
The Company's and Genta Jago's business may be materially adversely
affected by the continuing efforts of governmental and third party payers to
contain or reduce the costs of healthcare through various means. For example, in
certain foreign markets the pricing or profitability of healthcare products is
subject to government control. In the United States, there have been, and the
Company expects that there will continue to be, a number of federal and state
proposals to implement similar governmental control.
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While the Company cannot predict whether any such legislative or regulatory
proposals or reforms will be adopted, the adoption of any such proposal or
reform could adversely affect the commercial viability of the Company's and
Genta Jago's potential products. In addition, in both the United States and
elsewhere, sales of healthcare products are dependent in part on the
availability of reimbursement to the consumer from third party payers, such as
government and private insurance plans. Third party payers are increasingly
challenging the prices charged for medical products and services, and therefore
significant uncertainty exists as to the reimbursement of existing and newly-
approved healthcare products. If the Company or Genta Jago succeeds in bringing
one or more products to market, there can be no assurance that these products
will be considered cost effective and that reimbursement to the consumer will be
available or will be sufficient to allow the Company or Genta Jago to sell its
products on a competitive basis. Finally, given the above potential market
constraints on pricing, the availability of competitive products in these
markets may further limit the Company's and Genta Jago's flexibility in pricing
and in obtaining adequate reimbursement for its potential products. See
"MD&A--Certain Trends and Uncertainties--Potential Adverse Effect of
Technological Change and Competition."
Need for and Dependence on Qualified Personnel.
The Company's success is highly dependent on the hiring and retention
of key personnel and scientific staff. The loss of key personnel or the failure
to recruit necessary additional personnel or both is likely further to impede
the achievement of development objectives. There is intense competition for
qualified personnel in the areas of the Company's activities, and there can be
no assurance that Genta will be able to attract and retain the qualified
personnel necessary for the development of its business. The Company is actively
engaged in the search for a new Chief Financial Officer and a head of Research
and Development. In March 1998, the Company's Controller resigned and a
replacement is being sought. At the present time the Company believes its Stock
Option Plan is inadequate to provide sufficient incentives for the successful
recruitment of key personnel and a new plan will be proposed for stockholder
approval at the next annual stockholders' meeting. In addition, the current
senior officers and directors have not been granted options in accordance with
appointment offers since the current plan does have sufficient options
available. There can be no assurance that the stockholders will approve such a
plan or that, if approved, it will be adequate to enable recruitment of new, or
retention of existing, key employees and directors.
Product Liability Exposure; Limited Insurance Coverage.
The Company's, JBL's and Genta Jago's businesses expose them to
potential product liability risks that are inherent in the testing,
manufacturing, marketing and sale of human therapeutic products. If available,
product liability insurance for the pharmaceutical industry generally is
expensive. The Company has obtained a level of
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liability insurance coverage that it deems appropriate for its current stage of
development. However, there can be no assurance that the Company's present
insurance coverage is adequate. Such existing coverage may not be adequate as
the Company further develops products, and no assurance can be given that, in
the future, adequate insurance coverage will be available in sufficient amounts
or at a reasonable cost, or that a product liability claim would not have a
material adverse effect on the business or financial condition of the Company.
Fundamental Change.
The Company's Restated Certificate of Incorporation currently provides
that upon the occurrence of a "Fundamental Change," the holders of Series A
Preferred Stock have the option of requiring the Company to repurchase all of
each such holder's shares of Series A Preferred Stock at the Redemption Price,
an event that could result in the Company being required to pay to the holders
of Series A Preferred Stock stock or (in certain circumstances) cash in the
aggregate amount of approximately $27.2 million. Furthermore, if the Company is
required to redeem the Series A Preferred Stock it would also be required
(subject to certain conditions) to offer to redeem the Series D Preferred Stock
on a pari passu basis with the Series A Preferred Stock and with the same type
of consideration paid in redemption of the Series A Preferred Stock; upon a
Fundamental Change, the Company could, under certain circumstances, be required
to pay the holders of Series D Preferred Stock cash in the aggregate amount of
approximately $31.8 million (not including an additional $5.7 million that could
be payable upon redemption of 40,395 shares of Series D Preferred Stock issuable
upon exercise of certain warrants). "Fundamental Change" is defined as: (i) a
"person" or "Group" (as defined), together with any affiliates thereof, becoming
the beneficial owner (as defined) of Voting Shares (as defined) of the Company
entitled to exercise more than 60% of the total voting power of all outstanding
Voting Shares of the Company (including any Voting Shares that are not then
outstanding of which such person or Group is deemed the beneficial owner)
(subject to certain exceptions); (ii) any consolidation of the Company with, or
merger of the Company into, any other person, any merger of another person into
the Company, or any sale, lease or transfer of all or substantially all of the
assets of the Company to another person (subject to certain exceptions); (iii)
the sale, transfer or other disposition (or the entry into a commitment to sell,
transfer or otherwise dispose) of all or any portion of the shares of Genta Jago
held at any time by the Company (or the imposition of any material lien on such
shares which lien is not removed within 30 days of imposition) and the sale (or
functional equivalent of a sale) of all or substantially all of the assets of
Genta Jago or (iv) the substantial reduction or elimination of a public market
for the Common Stock as the result of repurchases, delisting or deregistration
of the Common Stock or corporate reorganization or recapitalization undertaken
by the Company.
The SEC Staff is currently in the process of reviewing a registration
statement filed by the Company, and has raised certain questions regarding the
Company's classification of the Preferred Stock as permanent (rather than
"mezzanine") equity. Management of the Company believes, based upon its
Certificate of Incorporation and the agreement pursuant to which the Preferred
Stock was issued, and after discussion with Company counsel, that the conditions
for redemption of the Preferred Stock require volitional acts undertaken by the
Company and are therefore solely within the control of the Company. If the SEC
Staff does not accept the Company's position, the Company will file an amendment
to this Form 10-K reclassifying the Preferred Stock as "mezzanine" rather than
permanent equity.
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Hazardous Materials; Environmental Matters
The Company's research and development and manufacturing processes
involve the controlled storage, use and disposal of hazardous materials,
biological hazardous materials and radioactive compounds. The Company is subject
to federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of such materials and certain waste products.
Although the Company believes that its safety procedures for handling and
disposing of such materials comply with the standards prescribed by such laws
and regulations, the risk of accidental contamination or injury from these
materials cannot be completely eliminated. In the event of such an accident, the
Company may be held liable for any damages that result, and any such liability
could exceed the resources of the Company. There can be no assurance that the
Company will not be required to incur significant costs to comply with
environmental laws and regulations in the future, nor that the operations,
business or assets of the Company will not be materially adversely affected by
current or future environmental laws or regulations. See "MD&A--Certain Trends
and Uncertainties--No Assurance of Regulatory Approval; Government Regulation"
for a discussion of the Spill.
Volatility of Stock Price; Market Overhang from Outstanding Convertible
Securities and Warrants.
The market price of the Company's Common Stock, like that of the common
stock of many other biopharmaceutical companies, has been highly volatile and
may be so in the future. Factors such as, among other things, the results of
pre-clinical studies and clinical trials by Genta, Genta Jago or their
competitors, other evidence of the safety or efficacy of products of Genta,
Genta Jago or their competitors, announcements of technological innovations or
new therapeutic products by the Company, Genta Jago or their competitors,
governmental regulation, developments in patent or other proprietary rights of
the Company, Genta Jago or their respective competitors, including litigation,
fluctuations in the Company's operating results, and market conditions for
biopharmaceutical stocks in general could have a significant impact on the
future price of the Common Stock. At the Company's Annual Meeting of
Stockholders held on April 4, 1997, the stockholders approved an amendment to
the Company's Restated Certificate of Incorporation effecting a one-for-ten
reverse stock split of its Common Stock. The stockholders also approved a
reduction of the Company's authorized shares of Common Stock from 150,000,000 to
70,000,000. The Company commenced trading on a post reverse split basis at the
commencement of trading on April 7, 1997. As of March 1, 1998, the Company had
5,737,756 shares of Common Stock outstanding. The Company intends to seek
stockholder approval of another reverse stock split at its next annual
stockholders' meeting. Future sales of shares of Common Stock by existing
stockholders, holders of preferred stock who might convert such preferred stock
into Common Stock, and option and warrant holders also could adversely affect
the market price of the Common Stock.
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No predictions can be made of the effect that future market sales of
the shares of Common Stock underlying the convertible securities and warrants
referred to under the caption "MD&A--Certain Trends and
Uncertainties--Subordination of Common Stock to Series A and Series D Preferred
Stock; Risk of Dilution; Anti-dilution Adjustments," or the availability of such
securities for sale, will have on the market price of the Common Stock
prevailing from time to time. Sales of substantial amounts of Common Stock, or
the perception that such sales might occur, could adversely affect prevailing
market prices.
Certain Interlocking Relationships; Potential Conflicts of Interest.
The Aries Trust, a Cayman Islands trust, and the Aries Domestic Fund,
L.P., a Delaware limited partnership (collectively, the "Aries Funds"), have the
contractual right to appoint a majority of the members of the Board of Directors
of the Company. The Aries Funds have designated Michael S. Weiss, Glenn L.
Cooper, M.D., Donald G. Drapkin, Bobby W. Sandage, Jr., PhD., and Andrew J.
Stein as nominees to the Board of Directors. Such persons were elected as
Directors of the Company. David R. Walner, the Secretary of the Company, is an
Associate Director and Secretary of Paramount Capital Asset Management, Inc.
("PCAM"). PCAM is the investment manager and general partner of The Aries Trust
and the Aries Domestic Fund, L.P., respectively. The Aries Funds currently do
not hold a controlling block of voting stock, although the Aries Funds have the
present right to appoint a majority of the Board of Directors, and to convert
and exercise their securities into a significant portion of the outstanding
Common Stock. See "MD&A--Certain Trends and Uncertainties--Concen- tration of
Ownership and Control" below. In addition to the Aries Funds' investments in the
Company that are disclosed in "Market for Registrant's Common Equity and Related
Stockholder Matters--Recent Sales of Unregistered Securities," above, the Aries
Funds also engaged in the following transactions: the Aries Funds purchased an
aggregate of 10,000 shares of Series D Preferred Stock and 50,000 Class D
Warrants in the Private Placement; on December 2, 1997, the Aries Funds
purchased an aggregate of 54,000 shares of Series A Preferred Stock; on December
29, 1997, warrants to purchase an aggregate of 1,000 shares of Series D
Preferred Stock and 5,000 Class D Warrants were allocated to the Aries Funds by
Paramount Capital, Inc., which warrants were received in connection with the
Private Placement; and on December 31, 1997, the Aries Funds converted the
outstanding principal of, and interest on, their respective Senior Secured
Convertible Bridge Notes of the Company into an aggregate of 52,415 shares of
Series D Preferred Stock. Dr. Lindsay A. Rosenwald, the President and sole
stockholder of PCAM, is also the President of Paramount Capital, Inc. and of
Paramount Capital Investments LLC, a New York-based merchant banking and venture
capital firm specializing in biotechnology companies ("PCI"). In the regular
course of its business, PCI identifies, evaluates and pursues investment
opportunities in biomedical and pharmaceutical products, technologies and
companies. Generally, Delaware corporate law requires that any transactions
between the Company and any of its affiliates be on
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terms that, when taken as a whole, are substantially as favorable to the Company
as those then reasonably obtainable from a person who is not an affiliate in an
arms-length transaction. Nevertheless, neither such affiliates nor PCI is
obligated pursuant to any agreement or understanding with the Company to make
any additional products or technologies available to the Company, nor can there
be any assurance, and the Company does not expect and investors in the Company
should not expect, that any biomedical or pharmaceutical product or technology
identified by such affiliates or PCI in the future will be made available to the
Company. In addition, certain of the current officers and directors of the
Company or certain of any officers or directors of the Company hereafter
appointed may from time to time serve as officers or directors of other
biopharmaceutical or biotechnology companies. There can be no assurance that
such other companies will not have interests in conflict with those of the
Company.
Concentration of Ownership and Control.
The Company's directors, executive officers and principal stockholders
and certain of their affiliates have the ability to influence the election of
the Company's directors and most other stockholder actions. See "MD&A--Certain
Trends and Uncertainties--Certain Interlocking Relationships; Potential
Conflicts of Interest." Accordingly, the Aries Funds have the ability to exert
significant influence over the election of the Company's Board of Directors and
other matters submitted to the Company's stockholders for approval. These
arrangements may discourage or prevent any proposed takeover of the Company,
including transactions in which stockholders might otherwise receive a premium
for their shares over the then current market prices. Such stockholders may
influence corporate actions, including influencing elections of directors and
significant corporate events. See also "MD&A--Certain Trends and
Uncertainties--Effect of Certain Anti-Takeover Provisions" below.
Effect of Certain Anti-Takeover Provisions.
The Company's Restated Certificate of Incorporation and By-laws include
provisions that could discourage potential takeover attempts and make attempts
by stockholders to change management more difficult. The approval of 66-2/3% of
the Company's voting stock is required to approve certain transactions and to
take certain stockholder actions, including the amendment of the By-laws and the
amendment of any of the anti-takeover provisions contained in the Company's
Restated Certificate of Incorporation. The Company's By-laws currently provide
that meetings of the stockholders may only be called by the Chairman of the
Board, the Chief Executive Officer or the Board of Directors. At its next annual
stockholders' meeting the Company intends to seek stockholder approval of an
amendment to its Restated Certificate of Incorporation that would have the
effect of eliminating the requirement that stockholder action be taken at a
meeting. Additionally, the Company has contractual obligations to certain of its
security holders that may impair potential takeovers. See
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"MD&A--Certain Trends and Uncertainties--Certain Interlocking Relationships;
Potential Conflicts of Interest." Further, pursuant to the terms of its
stockholder rights plan adopted in December 1993, the Company has distributed a
dividend of one right for each outstanding share of Common Stock. These rights
will cause a substantial dilution to a person or group that attempts to acquire
the Company on terms not approved by the Board of Directors and may have the
effect of deterring hostile takeover attempts. The stockholder rights plan was
amended to permit the consummation of the $3 million private placement in
February 1997 and the Private Placement in June 1997. Additionally, pursuant to
the Company's Restated Certificate of Incorporation, if any "person" or "Group"
(as defined), together with any affiliates thereof, becomes the beneficial owner
(as defined) of Voting Shares (as defined) of the Company entitled to exercise
more than 60% of the total voting power of all outstanding Voting Shares of the
Company (including any Voting Shares that are not then outstanding of which such
person or Group is deemed the beneficial owner) (subject to certain exceptions),
then a Fundamental Change (as defined) would occur and the Company would be
obligated to redeem the Series A and Series D Preferred Stocks. See
"MD&A--Certain Trends and Uncertainties Fundamental Change." This Fundamental
Change provision is a further disincentive for any person attempting to acquire
60% or more of the total voting power of the Company's Voting Shares.
Risks of Low-Priced Stock; Possible Effect of "Penny Stock" Rules on Liquidity
for the Company's Securities.
If the Company's securities were not listed on a national securities
exchange nor listed on a qualified automated quotation system, they may become
subject to Rule 15g-9 under the Exchange Act, which imposes additional sales
practice requirements on broker- dealers that sell such securities to persons
other than established customers and "accredited investors" (generally,
individuals with a net worth in excess of $1,000,000 or annual incomes exceeding
$200,000 or $300,000 together with their spouses). Rule 15g-9 defines "penny
stock" to be any equity security that has a market price (as therein defined) of
less than $5.00 per share or with an exercise price of less than $5.00 per
share, subject to certain exceptions including (i) the securities being quoted
on the Nasdaq National Market or SmallCap Market; (ii) the securities' issuer
having net tangible assets in excess of $2,000,000 and having been in continuous
operation for at least three years and (iii) the securities' issuer having
average revenues of at least $6,000,000 for the last three years (all three
exceptions enumerated above are currently met by the Company). For transactions
covered by Rule 15g-9, a broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transaction prior to sale. For any transaction involving a penny
stock, unless exempt, the rules require delivery, prior to any transaction in a
penny stock, of a disclosure schedule prepared by the SEC relating to the penny
stock market. Disclosure is also required to be made about sales commissions
payable to both the broker-dealer and the registered representative and current
quotations for the
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securities. Finally, monthly statements are required to be sent disclosing
recent price information for the penny stock held in the account and information
on the limited market in penny stock. Consequently, such Rule may affect the
ability of broker-dealers to sell the Company's securities and may affect the
ability of purchasers to sell any of the Company's securities in the secondary
market.
There can be no assurance that the Company's securities will continue
to qualify for exemption from the penny stock restrictions. In any event, even
if the Company's securities are exempt from such restrictions, the Company would
remain subject to Section 15(b)(6) of the Exchange Act, which gives the SEC the
authority to restrict any person from participating in a distribution of penny
stock, if the SEC finds that such a restriction would be in the public interest.
If the Company's securities were subject to the rules on penny stocks,
the market liquidity for the Company's securities could be materially adversely
affected.
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<PAGE>
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTAL DATA
Genta Incorporated
Index to Financial Statements Covered
by Reports of Independent Auditors
<TABLE>
<CAPTION>
GENTA INCORPORATED
<S> <C>
Report of Ernst & Young LLP, Independent Auditors..........................................59
Consolidated Balance Sheets at December 31, 1996 and 1997..................................61
Consolidated Statements of Operations for the years ended
December 31, 1995, 1996 and 1997...........................................................62
Consolidated Statements of Stockholders' Equity
for the years ended December 31, 1995, 1996 and 1997.......................................63
Consolidated Statements of Cash Flows for the years ended
December 31, 1995, 1996 and 1997...........................................................69
Notes to Consolidated Financial Statements.................................................70
GENTA JAGO TECHNOLOGIES B.V. (A DEVELOPMENT STAGE COMPANY)
Report of Ernst & Young LLP, Independent Auditors..........................................93
Balance Sheets at December 31, 1996 and 1997...............................................94
Statements of Operations for the years ended December 31, 1995, 1996 and 1997
and for the period December 15, 1992 (inception) through December 31, 1997.................95
Statement of Stockholders' Equity (Net Capital Deficiency) for the Period
December 15, 1992 (inception) through December 31, 1997....................................96
Statements of Cash Flows for the years ended December 31, 1995, 1996 and
1997 and for the period December 15, 1992 (inception) through December 15, 1997............97
Notes to Financial Statements..............................................................98
</TABLE>
- 58 -
<PAGE>
Report of Ernst & Young LLP, Independent Auditors
The Board of Directors and Stockholders
Genta Incorporated
We have audited the accompanying consolidated balance sheets of Genta
Incorporated as of December 31, 1996 and 1997 and the related consolidated
statements of operations, stockholders' equity, and cash flows for each of the
three years in the period ended December 31, 1997. These financial statements
are the responsibility of the Company's management. Our responsibility is to
express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Genta Incorporated
at December 31, 1996 and 1997 and the consolidated results of its operations and
its cash flows for each of the three years in the period ended December 31, 1997
in conformity with generally accepted accounting principles.
As discussed in Note 1 to the consolidated financial statements, the Company has
incurred substantial and continuing operating losses since inception and
management expects that these losses will continue for the foreseeable future.
These conditions raise substantial doubt about the Company's ability to continue
as a going concern. Management's plans as to this matter are also described in
Note 1. The 1997 financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
- 59 -
<PAGE>
As disclosed in Note 8 to the financial statements, the Company restated its
operating results for 1996 to include the effects of recording imputed non-cash
interest costs totaling $666,667 and imputed non-cash dividends on preferred
stock totaling $2,348,000 not previously recorded in operating results for 1996.
The Company also restated its operating results for 1995 to include the effect
of recording imputed non-cash dividends on preferred stock totaling $1,000,000
not previously recorded in operating results for 1995. This had the effect of
increasing net loss applicable to common shareholders by $3,014,667 and
$1,000,000 in 1996 and 1995, respectively, and increasing net loss per share
(basic and diluted) by $(1.01) and $(.51) in 1996 and 1995, respectively.
San Diego, California
April 15, 1998
- 60 -
<PAGE>
Genta Incorporated
Consolidated Balance Sheets
<TABLE>
<CAPTION>
December 31,
------------------------------------------
1996 1997
------------------------------------------
(restated)
Assets
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 532,013 $ 1,202,668
Short-term investments, available-for-sale - 7,253,756
Trade accounts receivable 602,696 431,046
Notes receivable from officers and employees 62,000 -
Inventories 992,243 826,008
Other current assets 185,164 218,513
------------------------------------------
Total current assets 2,374,116 9,931,991
Property and equipment, net 3,634,281 1,718,150
Intangibles, net 4,022,242 3,390,032
Deposits and other assets 1,138,745 713,730
------------------------------------------
Total assets $11,169,384 $15,753,903
==========================================
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,179,056 $ 882,111
Payable to research institution 551,213 602,658
Accrued payroll 782,280 548,295
Other accrued expenses 981,087 992,660
Deferred revenue 193,121 198,570
Short-term notes payable 350,000 -
Current portion of notes payable and capital lease obligations 1,332,304 900,558
------------------------------------------
Total current liabilities 5,369,071 4,124,852
Notes payable and capital lease obligations, less current portion 119,578 -
Deficit in joint venture 1,606,503 2,204,053
Stockholders' equity:
Preferred stock; 5,000,000 shares authorized, convertible preferred shares
outstanding:
Series A convertible preferred stock, $.001 par value; 528,100 and
456,600 shares issued and outstanding at December 31, 1996 and 1997,
respectively; liquidation value is $27,396,000
at December 31, 1997 528 457
Series C convertible preferred stock, $.001 par value; 1,424
and no shares issued and outstanding at December 31, 1996
and 1997, respectively 1 -
Series D convertible preferred stock, $.001 par value; $100
stated value, no shares and 226,995 shares issued and
outstanding at December 31, 1996 and 1997, respectively;
liquidation value is $31,779,300 at December 31, 1997 - 227
Common stock, $.001 par value; 70,000,000 shares authorized;
3,999,368 and 5,712,363 shares issued and outstanding at
December 31, 1996 and 1997, respectively 3,999 5,712
Additional paid-in capital 109,490,222 126,320,493
Accumulated deficit (109,042,074) (124,467,891)
Accrued dividends payable in common stock 3,671,532 4,566,000
Notes receivable from stockholders (49,976) -
------------------------------------------
Total stockholders' equity 4,074,232 6,424,998
------------------------------------------
Total liabilities and stockholders' equity $11,169,384 $15,753,903
==========================================
</TABLE>
See accompanying notes.
- 61 -
<PAGE>
Genta Incorporated
Consolidated Statements of Operations
<TABLE>
<CAPTION>
YEARS ENDED DECEMBER 31,
--------------------------------------------
1995 1996 1997
--------------------------------------------
(restated) (restated)
<S> <C> <C> <C>
Revenues:
Product sales $ 3,781,983 $ 4,924,694 $ 4,701,649
Gain on sale of technology -- 373,261 --
Contract revenue from Genta Jago 2,747,678 1,558,962 350,097
Collaborative research and
development 1,125,000 -- 50,000
--------------------------------------------
7,654,661 6,856,917 5,101,746
Costs and expenses:
Cost of products sold 1,899,216 2,479,337 3,099,078
Research and development 13,102,821 6,777,043 5,387,095
Charge for acquired in-process
research and development 4,762,000 -- --
Selling, general and administrative 6,360,402 6,254,366 8,075,229
--------------------------------------------
26,124,439 15,510,746 16,561,402
--------------------------------------------
Loss from operations (18,469,778) (8,653,829) (11,459,656)
Equity in net loss of joint venture (6,913,180) (2,712,183) (1,193,321)
Other income (expense):
Interest income 348,470 159,165 550,195
Interest expense (331,226) (885,602) (3,323,035)
--------------------------------------------
Net loss (25,365,714) (12,092,449) (15,425,817)
Dividends accrued on preferred stock (2,551,726) (2,524,701) (1,694,677)
Dividends imputed on preferred stock (1,000,000) (2,348,000) (16,158,000)
--------------------------------------------
Net loss applicable to common shares $(28,917,440) $(16,965,150) $(33,278,494)
============================================
Net loss per share (basic and diluted) $ (14.82) $ (5.69) $ (7.52)
============================================
Shares used in computing net loss per
share 1,951,862 2,983,449 4,422,409
============================================
</TABLE>
See accompanying notes.
- 62 -
<PAGE>
Genta Incorporated
Consolidated Statements of Stockholders' Equity
<TABLE>
<CAPTION>
CONVERTIBLE
PREFERRED STOCK COMMON STOCK
---------------------------
---------------------------
SHARES AMOUNT SHARES AMOUNT
--------------------------- ---------------------------
<S> <C> <C> <C> <C>
Balance at December 31, 1994 600,000 $ 600 1,387,731 $ 1,387
Issuance of common stock - - 573,441 573
Issuance of common stock upon conversion
of promissory notes - - 177,790 178
Issuance of common stock for acquired
in-process research and development - - 124,000 124
Issuance of Series B convertible preferred stock 3,000 3 - -
Issuance of warrants to purchase common stock - - - -
Issuance of common stock on exercise of options - - 732 1
Issuance of common stock as dividend on preferred
stock - - 132,863 133
Dividends accrued on preferred stock - - - -
Repayment of notes receivable from stockholders - - - -
Amortization of deferred compensation - - - -
Net loss - - - -
-----------------------------------------------------------
Balance at December 31, 1995 603,000 603 2,396,557 2,396
Issuance of Series C convertible preferred stock 6,000 6 - -
Issuance of Series C convertible preferred stock
upon conversion of promissory notes 1,044 1 - -
Issuance of common stock upon conversion of
Series A convertible preferred stock and related
accrued dividends (71,900) (72) 255,446 255
Issuance of common stock upon conversion of Series
B convertible preferred stock and related accrued (3,000) (3) 226,943 227
dividends
</TABLE>
- 63 -
<PAGE>
Genta Incorporated
Consolidated Statements of Stockholders' Equity
<TABLE>
<CAPTION>
ACCRUED
ADDITIONAL DIVIDENDS IN
PAID-IN ACCUMULATED PREFERRED
CAPITAL DEFICIT STOCK
----------------------------------------------------------
Balance at December 31, 1994 $ 85,797,104 $(71,583,911) $ 1,420,862
Issuance of common stock 9,164,704 - -
Issuance of common stock upon conversion
of promissory notes 3,022,260 - -
Issuance of common stock for acquired
in-process research and development 1,611,876 - -
Issuance of Series B convertible preferred stock 2,774,897 - -
Issuance of warrants to purchase common stock 173,118 - -
Issuance of common stock on exercise of options 3,661 - -
Issuance of common stock as dividend on preferred
stock 2,399,779 - (2,400,000)
Dividends accrued on preferred stock (2,551,726) - 2,551,726
Repayment of notes receivable from stockholders - - -
Amortization of deferred compensation - - -
Net loss - (25,365,714) -
----------------------------------------------------------
Balance at December 31, 1995 102,395,673 (96,949,625) 1,572,588
Issuance of Series C convertible preferred stock 5,492,633 - -
Issuance of Series C convertible preferred stock
upon conversion of promissory notes 1,044,000 - -
Issuance of common stock upon conversion of
Series A convertible preferred stock and related
accrued dividends 326,838 - (327,021)
Issuance of common stock upon conversion of Series
B convertible preferred stock and related accrued 33,783 - (34,007)
dividends
<CAPTION>
NOTES RECEIVABLE TOTAL
FROM DEFERRED STOCKHOLDERS'
STOCKHOLDERS COMPENSATION EQUITY
------------------------------------------------------------
<S> <C> <C> <C>
Balance at December 31, 1994 $ (74,726) $ (64,836) $15,496,486
Issuance of common stock - - 9,165,277
Issuance of common stock upon conversion
of promissory notes - - 3,022,438
Issuance of common stock for acquired
in-process research and development - - 1,612,000
Issuance of Series B convertible preferred stock - - 2,774,900
Issuance of warrants to purchase common stock - - 173,118
Issuance of common stock on exercise of options - - 3,662
Issuance of common stock as dividend on preferred
stock - - (88)
Dividends accrued on preferred stock - - -
Repayment of notes receivable from stockholders 24,750 - 24,750
Amortization of deferred compensation - 64,836 64,836
Net loss - - (25,365,714)
------------------------------------------------------------
Balance at December 31, 1995 (49,976) - 6,971,659
Issuance of Series C convertible preferred stock - - 5,492,639
Issuance of Series C convertible preferred stock
upon conversion of promissory notes - - 1,044,001
Issuance of common stock upon conversion of
Series A convertible preferred stock and related
accrued dividends - - 3,595,000
Issuance of common stock upon conversion of Series
B convertible preferred stock and related accrued - - -
dividends
</TABLE>
- 64 -
<PAGE>
Genta Incorporated
Consolidated Statements of Stockholders' Equity
<TABLE>
<CAPTION>
CONVERTIBLE
PREFERRED STOCK COMMON STOCK
--------------------------- ---------------------------
SHARES AMOUNT SHARES AMOUNT
--------------------------- ---------------------------
<S> <C> <C> <C> <C>
Issuance of common stock upon conversion of Series C
convertible preferred
stock and related accrued
dividends (5,620) (6) 524,749 525
Issuance of common stock upon
conversion of convertible debentures - - 587,790 588
Issuance of warrants to purchase
common stock for patent legal services - - - -
Issuance of common stock on exercise of options - - 7,882 8
Dividends accrued on preferred stock - - - -
Interest imputed on convertible debentures - - - -
Net loss - - - -
-----------------------------------------------------------
Balance at December 31, 1996 529,524 530 3,999,367 3,999
Issuance of common stock - - 38,400 38
Retirement common stock in exchange for
forgiveness of note receivable - - (1,250) (1)
Issuance of common stock upon conversion of
Series A convertible preferred stock and
related accrued dividends (71,500) (71) 518,742 519
Issuance of common stock upon conversion of
Series C convertible preferred stock and
related accrued dividends (1,424) (1) 952,841 953
Issuance of common stock upon conversion of
convertible debentures - - 204,263 204
Issuance of Series D convertible preferred stock 161,580 162 - -
</TABLE>
- 65 -
<PAGE>
Genta Incorporated
Consolidated Statements of Stockholders' Equity
<TABLE>
<CAPTION>
ACCRUED
ADDITIONAL DIVIDENDS ON
PAID-IN ACCUMULATED PREFERRED
CAPITAL DEFICIT STOCK
----------------------------------------------------------
<S> <C> <C>
Issuance of common stock upon conversion
of Series C convertible preferred
stock and related accrued
dividends 64,210 - (64,729)
Issuance of common stock upon
conversion of convertible debentures 1,598,011 - -
Issuance of warrants to purchase
common stock for patent legal services 221,543 - -
Issuance of common stock on exercise of options 171,565 - -
Dividends accrued on preferred stock (2,524,701) - 2,524,701
Interest imputed on convertible debentures 666,667 - -
Net loss - (12,092,449) -
----------------------------------------------------------
Balance at December 31, 1996 109,490,222 (109,042,074) 3,671,532
Issuance of common stock 2,000 - -
Retirement common stock in exchange for
forgiveness of note receivable - - -
Issuance of common stock upon conversion of
Series A convertible preferred stock and
related accrued dividends 714,552 - (715,000)
Issuance of common stock upon conversion of
Series C convertible preferred stock and
related accrued dividends 84,257 - (85,209)
Issuance of common stock upon conversion of
convertible debentures 358,355 - -
Issuance of Series D convertible preferred stock 13,957,100 - -
<CAPTION>
NOTES RECEIVABLE TOTAL
FROM DEFERRED STOCKHOLDERS'
STOCKHOLDERS COMPENSATION EQUITY
------------------------------------------------------------
<S>
Issuance of common stock upon conversion <C> <C> <C>
of Series C convertible preferred
stock and related accrued
dividends - - -
Issuance of common stock upon
conversion of convertible debentures - - 1,598,599
Issuance of warrants to purchase
common stock for patent legal services - - 221,543
Issuance of common stock on exercise of options - - 171,573
Dividends accrued on preferred stock - - -
Interest imputed on convertible debentures - - 666,667
Net loss - (12,092,449)
------------------------------------------------------------
Balance at December 31, 1996 (49,976) - 4,074,252
Issuance of common stock - - 42,038
Retirement common stock in exchange for
forgiveness of note receivable 49,976 - 49,975
Issuance of common stock upon conversion of
Series A convertible preferred stock and
related accrued dividends - - -
Issuance of common stock upon conversion of
Series C convertible preferred stock and
related accrued dividends - - -
Issuance of common stock upon conversion of
convertible debentures - - 358,559
Issuance of Series D convertible preferred stock - - 13,957,262
</TABLE>
- 66 -
<PAGE>
Genta Incorporated
Consolidated Statements of Stockholders' Equity
<TABLE>
<CAPTION>
CONVERTIBLE
PREFERRED STOCK COMMON STOCK
--------------------------- ---------------------------
SHARES AMOUNT SHARES AMOUNT
--------------------------- ---------------------------
<S> <C> <C>
Issuance of Series D convertible preferred stock
upon conversion of senior
secured convertible bridge
notes and accrued interest 65,415 65 - -
Dividends accrued on preferred stock - - - -
Issuance of warrants to purchase common
stock in connection with line of credit - - - -
Interest imputed on convertible
debentures - - - -
Net loss - - - -
-----------------------------------------------------------
Balance at December 31, 1997 683,595 $ 684 5,712,363 $5,712
===========================================================
</TABLE>
See accompanying notes.
- 67 -
<PAGE>
Genta Incorporated
Consolidated Statements of Stockholders' Equity
<TABLE>
<CAPTION>
ACCRUED
ADDITIONAL DIVIDENDS ON
PAID-IN ACCUMULATED PREFERRED
CAPITAL DEFICIT STOCK
-----------------------------------------------------------
<S> <C> <C> <C>
Issuance of Series D convertible preferred stock
upon conversion of senior
secured convertible bridge
notes and accrued interest 3,270,684 - -
Dividends accrued on preferred stock (1,694,677) - 1,694,677
Issuance of warrants to purchase common
stock in connection with line of credit 98,000 - -
Interest imputed on convertible
debentures 3,000,000 - -
Net loss - (15,425,817) -
-----------------------------------------------------------
Balance at December 31, 1997 $126,320,493 $(124,467,891) $4,566,000
===========================================================
<CAPTION>
NOTES RECEIVABLE TOTAL
FROM DEFERRED STOCKHOLDERS'
STOCKHOLDERS COMPENSATION EQUITY
--------------------------------------------------------------
<S>
Issuance of Series D convertible preferred stock <C> <C> <C>
upon conversion of senior
secured convertible bridge
notes and accrued interest - - 3,270,749
Dividends accrued on preferred stock - - -
Issuance of warrants to purchase common
stock in connection with line of credit - - 98,000
Interest imputed on convertible
debentures - - 3,000,000
Net loss - - (15,425,817)
--------------------------------------------------------------
Balance at December 31, 1997 $ - $ - $6,424,998
==============================================================
</TABLE>
See accompanying notes.
- 68 -
<PAGE>
Genta Incorporated
Consolidated Statements of Cash Flows
<TABLE>
<CAPTION>
Years ended December 31,
--------------------------------------------------------------
1995 1996 1997
--------------------------------------------------------------
<S> <C> <C> <C>
Operating activities
Net loss $(25,365,714) $(12,092,449) $(15,425,817)
Items reflected in net loss not requiring cash:
Depreciation and amortization 1,761,530 1,518,142 1,022,432
Equity in net loss of joint venture 6,913,180 2,712,183 1,193,321
Loss on disposal of fixed assets - - 1,130,809
Loss on abandonment of patents - - 600,000
Interest accrued on convertible notes and debentures - - 279,308
Fair value of warrants issued in connection with line of - - 98,000
credit
Forgiveness of shareholder note - - 49,976
Fair value of common stock issued for severance and - - 42,038
services
Charge for acquired in-process research and development
and other 3,807,556 - -
Interest imputed on convertible debentures - 666,667 3,000,000
Changes in operating assets and liabilities:
Accounts and notes receivable 294,012 168,600 233,650
Inventories 106,909 (289,599) 166,235
Other current assets 366,790 (33,241) (33,349)
Accounts payable, accrued expenses and other 467,738 (803,347) (467,922)
Deferred revenue (976,468) 44,589 5,449
--------------------------------------------------------------
Net cash used in operating activities (12,624,467) (8,108,455) (8,105,870)
INVESTING ACTIVITIES
Purchase of short-term investments - (1,497,775) (9,763,493)
Maturities of short-term investments 3,843,685 1,497,775 2,509,737
Purchase of property and equipment (778,964) (115,922) (34,246)
Proceeds from sale of property and equipment - - 70,691
Loans receivable from joint venture (7,722,255) (846,784) (595,771)
Deposits and other (2,021,908) 642,654 (67,331)
--------------------------------------------------------------
Net cash used in investing activities (6,679,442) (320,052) (7,880,413)
FINANCING ACTIVITIES
Proceeds from notes payable 4,877,471 2,176,500 3,000,000
Repayment of notes payable and capital leases (1,743,728) (1,948,438) (300,324)
Proceeds from issuance of preferred stock, net - 8,267,539 13,957,262
Proceeds from issuance of common stock, net 9,168,939 171,573 -
Other 13,762 21,591 -
--------------------------------------------------------------
Net cash provided by financing activities 12,316,444 8,688,765 16,656,938
--------------------------------------------------------------
Increase (decrease) in cash and cash equivalents (6,987,465) 260,258 670,655
Cash and cash equivalents at beginning of year 7,259,220 271,755 532,013
--------------------------------------------------------------
Cash and cash equivalents at end of year $ 271,755 $ 532,013 $1,202,668
==============================================================
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid $ 298,432 $ 225,186 $ 33,914
==============================================================
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND
FINANCING ACTIVITIES:
Capital lease obligations entered into for equipment 622,746 - -
Preferred stock dividend accrued 2,551,726 2,524,701 1,694,677
Dividends imputed on preferred stock 1,000,000 2,348,000 16,158,000
Common stock issued in payment of dividends on preferred 2,399,912 425,757 800,209
stock
Preferred stock issued upon conversion of notes payable and
accrued interest - 1,044,001 -
Preferred stock issued for receivable 2,774,900 - -
Common stock issued upon conversion of notes and
convertible debentures and accrued interest 3,022,438 1,598,599 358,559
Exchange of deposits for purchase of equipment - 1,200,000 251,000
Preferred stock issued upon conversion of short-term notes
payable and accrued interest - - 3,270,749
See accompanying notes.
</TABLE>
- 69 -
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements
December 31, 1997
1. Organization and Significant Accounting Policies
Organization and Business
Genta Incorporated ("Genta" or the "Company") is an emerging
biopharmaceutical company engaged in the development of a pipeline of
pharmaceutical products. The Company owns 50% of a drug delivery system joint
venture with Jagotec AG ("Jagotec") named Genta Jago Technologies B.V. ("Genta
Jago") established to develop oral controlled-release drugs.. The Company's
research efforts have been focused on the development of proprietary
oligonucleotide pharmaceuticals intended to block or regulate the production of
disease-related proteins at the genetic level. The Company also manufactures and
markets specialty biochemicals and intermediate products to the in vitro
diagnostic and pharmaceutical industries through its manufacturing subsidiary,
JBL Scientific, Inc. ("JBL").
Basis of Presentation
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. However, the Company has had recurring
operating losses since inception and management expects that they will continue
for the next several years. The Company is actively seeking collaborative
agreements, additional equity financing and other financing arrangements with
potential corporate partners and other sources. However, there can be no
assurance that any such collaborative agreements or other sources of funding
will be available on favorable terms, if at all. These conditions raise
substantial doubt about the Company's ability to continue as a going concern.
The 1997 financial statements do not include any adjustments that might result
from the outcome of this uncertainty.
As disclosed in Note 8 to the financial statements, the Company restated
its operating results for 1996 to include the effects of recording imputed
non-cash interest costs totaling $666,667 and imputed non-cash dividends on
preferred stock totaling $2,348,000 not previously recorded in operating results
for 1996. The Company also restated its operating results for 1995 to include
the effect of recording imputed non-cash dividends on preferred stock totaling
$1,000,000 not previously recorded in operating results for 1995. This had the
effect of increasing net loss applicable to common shareholders by $3,014,667
and $1,000,000 in 1996 and 1995, respectively, and increasing net loss per share
(basic and diluted) by $(1.01) and $(.51) in 1996 and 1995, respectively.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company
and its wholly owned subsidiaries, JBL and Genta Pharmaceuticals Europe, S.A.,
the Company's European subsidiary based in Marseilles, France. All significant
intercompany accounts and transactions have been eliminated in consolidation.
Investment in Joint Venture
The Company has a 50% ownership interest in a joint venture, Genta Jago, a
Netherlands corporation. The investment in joint venture is accounted for under
the equity method (Note 5).
-70-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
disclosures made in the accompanying notes to the financial statements. Actual
results could differ from those estimates.
Revenue Recognition and Major Customers
Revenue from product sales is recognized upon shipment. One customer, a
European distributor, accounted for approximately 21%, 27% and 25% of product
sales during the years ended December 31, 1995, 1996 and 1997, respectively. One
other customer, who accounted for less than 10% of product sales in 1997,
accounted for approximately 16% of product sales during the year ended December
31, 1995. Collaborative research and development revenues are recorded as
earned, generally ratably, as research and development activities are performed
under the terms of the contracts. Payments received in excess of amounts earned
are deferred.
Cash, Cash Equivalents and Short-Term Investments
Cash and cash equivalents consist of money market type funds and highly
liquid debt instruments with remaining maturities of three months or less when
purchased. Short-term investments consist of corporate notes, all of which
mature within one year from December 31, 1997. The estimated fair value of each
investment security approximates the amortized cost and therefore, no unrealized
gains or losses existed as of December 31, 1997.
Concentration of Credit Risk
The Company markets its specialty biochemical and intermediate products to
the pharmaceutical and diagnostic industries. Generally, collateral is not
required on the Company's sales. Credit losses have historically been
insignificant and within management's expectations.
The Company invests its excess cash in debt instruments of corporations
with strong credit ratings. The Company has established guidelines relative to
diversification and maturities that attempt to maintain safety and liquidity.
These guidelines are periodically reviewed and modified to take advantage of
trends in yields and interest rates. The Company has not experienced any
significant losses on its cash equivalents or short-term investments.
-71-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
Inventories
Inventories are stated at the lower of cost (first-in, first-out) or
market.
Property and Equipment
Property and equipment is stated at cost and depreciated over the
estimated useful lives of the assets using the straight-line method. Leasehold
improvements are stated at cost and amortized over the shorter of the estimated
useful lives of the assets or the lease term. Amortization of equipment under
capital leases is reported with depreciation of property and equipment.
Intangible Assets
Intangible assets, consisting primarily of capitalized patent costs and
purchased proprietary technology, are amortized using the straight line basis
over a term of 5 years (formerly 5-17 years) for issued patents, 14 years for
purchased proprietary technology and 5-7 years for organizational and other
amortizable costs. The Company's policy is to evaluate the appropriateness of
the carrying values of the unamortized balances of intangible assets on the
basis of estimated future cash flows (undiscounted) and other factors. If such
evaluation were to indicate an impairment of these intangible assets, such
impairment would be recognized by a write-down of the applicable assets. The
Company continues to evaluate the continuing value of patents and patent
applications, particularly as expenses to prosecute or maintain these patents
come due. Through this evaluation, the Company may elect to continue to maintain
these patents; seek to out-license them; or abandon them. In 1997, as a result
of such evaluation, the Company recorded charges to General & Administrative
Expenses of $600,000 for specific capitalized patents no longer related to the
research and development efforts of the Company.
Dividends
The number of shares of common stock issued in payment of dividends is
based on the fair market value of such shares of common stock on the date the
dividends become due.
Stock Options
The Company has elected to follow Accounting Principles Board Opinion No.
25, "Accounting for Stock Issued to Employees" (APB 25) and related
Interpretations in accounting for its employee stock options because the
alternative fair value accounting provided for under SFAS No. 123, "Accounting
for Stock-Based Compensation" (SFAS No. 123), requires use of option valuation
models that were not developed for use in valuing employee stock options.
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
Under APB 25, deferred compensation is recorded for the excess of the fair
value of the stock on the date of the option grant, over the exercise price of
the option. The deferred compensation is amortized over the vesting period of
the option.
The Company accounts for stock option grants and similar equity
instruments granted to non-employees under the fair value method provided for in
SFAS No. 123.
Net Loss Per Common Share
As required, the Company adopted SFAS No. 128, "Earnings Per Share," for
the year ended December 31, 1997. SFAS No. 128 changes the method used to
calculate earnings per share and requires the restatement of all prior periods.
Under SFAS No. 128, the Company is required to present basic and diluted
earnings per share if applicable. Basic earnings per share is based on the
weighted average number of shares outstanding during the period. Diluted
earnings per share includes the weighted average number of shares outstanding
and gives effect to potentially dilutive common shares such as options, warrants
and convertible debt and preferred stock outstanding.
Net loss per common share for the years ended December 31, 1995, 1996 and
1997 is based on the weighted average number of shares of common stock
outstanding during the periods. Potentially dilutive securities include options,
warrants and convertible preferred stock; however, such securities have not been
included in the calculation of the net loss per common share as their effect is
antidilutive where, as here, there is loss rather than earnings. Therefore,
there is no difference between the basic and diluted net loss per common share
for any of the periods presented.
Recently Issued Accounting Standards
In June 1997, the Financial Accounting Standards Board issued SFAS No.
130, "Reporting Comprehensive Income," and SFAS No. 131, "Segment Information."
Both of these standards are effective for fiscal years beginning after December
15, 1997. SFAS No. 130 requires that all components of comprehensive income,
including net income, be reported in the financial statements in the period in
which they are recognized. Comprehensive income is defined as the change in
equity during a period from transactions and other events and circumstances from
non-owner sources. Net income and other comprehensive income, including foreign
currency translation adjustments, and unrealized gains and losses on
investments, shall be reported, net of their related tax effect, to arrive at
comprehensive income. The Company does not believe that comprehensive income or
loss has been materially different than net income or loss. SFAS No. 131 amends
the requirements for public enterprises to report financial and descriptive
information about its enterprise for which separate financial information is
available and is evaluated regularly
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
by the Company in deciding how to allocate resources and in assessing
performance. The financial information is required to be reported on the basis
that is used internally for evaluating the segment performance. The Company does
not believe adoption of SFAS No. 131 will have a material impact on the
Company's financial statements.
Reclassification
Certain prior year amounts have been reclassified to conform with the
current year presentation.
2. Inventories
Inventories are comprised of the following:
December 31,
1996 1997
--------------------------
Raw materials and supplies ................... $342,875 $329,691
Work-in-process .............................. 272,259 141,120
Finished goods ............................... 377,109 355,197
--------------------------
$992,243 $826,008
==========================
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
3. Property and Equipment
Property and equipment is comprised of the following:
December 31,
1996 1997
------------------------------
Equipment .................................. $ 4,093,563 $ 3,923,653
Leasehold improvements ..................... 1,128,520 724,456
Furniture and fixtures ..................... 105,318 59,739
Construction in progress ................... 624,167 --
------------------------------
5,951,568 4,707,848
Less accumulated depreciation and
amortization ............................ (2,317,287) (2,989,698)
------------------------------
$ 3,634,281 $ 1,718,150
==============================
Cost and accumulated amortization of equipment under capital leases at
December 31, 1996 was $200,000 and $80,000, respectively. No equipment was
subject to capital leases at December 31, 1997.
4. Notes Receivable from Officers and Employees
At December 31, 1996, notes receivable consisted of loans made to officers
and employees to facilitate their relocation. Generally, such loans are secured
by each individual's residence, bear interest at approximately 7.0% per annum,
and mature on the earlier of: (i) such officer's or employee's termination, (ii)
five years from the date of issuance, or (iii) on the date of sale of the
property. The notes were repaid in fiscal 1997 in connection with the
termination of the related employees' employment.
5. Genta Jago Joint Venture
In 1992, Genta and Jagotec determined to enter into a joint venture (Genta
Jago). The Company's purpose in establishing Genta Jago was to obtain a
limited-scope license to Jagotec's GEOMATRIX technology in the hopes of
producing shorter-term earnings than were expected from the Company's
Anticode(TM) antisense programs. Genta contributed $4 million in cash to Genta
Jago as well as the rights to apply its Anticode(TM) oligonucleotide technology
to six products and also contributed the Initial License referred to below.
Genta issued 120,000 shares of Common Stock valued at $7.2 million to Jagotec in
1992 as consideration for a license (the "Initial License") for Genta to use
Jagotec's GEOMATRIX Technology with respect to
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
approximately 25 products, under the condition that Genta then contribute such
technology to Genta Jago, which Genta did. The $7.2 million fair value assigned
to the 120,000 unregistered common shares issued to Jagotec by Genta for the
GEOMATRIX license represented a 33% discount from the trading market price of
registered shares on the date of formation of the joint venture (December 15,
1992) and was expensed as acquired in-process research and development in 1992
on Genta's books. The value of the Common Stock Genta issued to Jagotec was
considered by the parties to be substantially below the actual fair market value
of the Initial License. The $4.0 million in cash paid to Genta Jago by Genta was
recorded on Genta's books as investment in joint venture. The shares of Common
Stock issued to Jagotec were valued at their fair market value at the date of
issuance and were expensed as Acquired in-process research and development, as
there were no alternative future uses for the acquired technology, and
realization of ultimate profits from the acquired technology was not assured.
Thus, upon the acquisition of the license, Genta had no carrying value assigned
to the GEOMATRIX technology, and when Genta contributed both its proprietary
Anticode and its recently in-licensed GEOMATRIX technologies to Genta Jago,
there was no accounting for such capital contributions. Since its $4 million
cash investment in Genta Jago was paid to the joint venture to cover initial
funding of development, Genta initially carried it as an Investment in joint
venture on its balance sheet.
In 1994, separate from the original 1992 joint venture agreement, Genta
and Jagotec began negotiations to expand Genta Jago to include the GEOMATRIX
technology as applied to 35 additional products (the "Additional License"). In
1994, Jagotec granted Genta, for $1.85 million, an option (the "Expansion
Option"), exercisable solely at Genta's discretion through April 30, 1995, to
expand the joint venture by purchasing from Jagotec the Additional License at
what the parties believed was a substantial discount to its actual value, on the
condition that Genta then contribute it to the joint venture. The $1.85 million
was considered by Genta to be a partial cost of acquiring the Additional
License, and, since it was not refundable under any circumstances and there was
no assurance of future recoverability of the $1.85 million (i.e. recoverability
was dependent upon Genta Jago achieving profitability), Genta expensed such
payment in 1994 as Acquired in-process research and development. An additional
$2.0 million (the "Deposit") was deposited with Jagotec in 1994, but would only
be retained by Jagotec, as partial payment of the exercise price for the
Expansion Option, if Genta actually exercised the Expansion Option. If such
Expansion Option was not exercised, the $2.0 million Deposit would be
transferred to Genta Jago in the form of working capital loans payable by Genta
Jago to Genta. Accordingly, at December 31, 1994, the $2.0 million Deposit was
recorded on Genta's books as a loan receivable from joint venture, and would
remain so until its ultimate use was identified.
Pursuant to the terms of the Expansion Option, for Genta to exercise the
Expansion Option, Genta would have had to pay Jagotec an aggregate of $3.15
million in cash and 124,000 shares of Common Stock, valued at $1.6 million
(based on the trading price at such time). The
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
parties agreed the $3.15 million in cash would consist of (i) the $2.0 million
Deposit made by Genta in 1994, which would be applied to the Expansion Option's
exercise price upon Genta's election, in 1995, to exercise such Expansion
Option; and (ii) an additional cash payment of $1.15 million to exercise the
Expansion Option to be paid by Genta in 1995. In 1995, Genta exercised the
Expansion Option. Consideration for the Expansion Option exercise paid in 1995
represented an aggregate amount of $4.8 million. This amount was expensed as
Acquired in-process research and development in 1995, as there were no
identified alternative future uses for the Additional License and recoverability
of the $4.8 million was not assured.
The technological feasibility of the acquired in-process research and
development had not yet been established and the technology had no future
alternative uses at the date of acquisition. Furthermore, due to continuing
uncertainties regarding the Company's ability to demonstrate bioequivalence of
potential products, management is unable to make estimates regarding the
remaining efforts necessary to develop the acquired, in-process technology into
a commercially viable product. However, it is expected that any such development
would require significant cash resources.
The Company provides funding to Genta Jago pursuant to a working capital
loan agreement which expires in October 1998. See "MD&A--Liquidity and Capital
Resources." These advances were structured as working capital loans, to give
Genta the protections of a debt holder with respect to such amounts and to
maintain Genta's and Jagotec's respective equity ownership in Genta Jago at a
50/50 ratio. As of December 31, 1997, the Company had advanced working capital
loans of approximately $15.8 million to Genta Jago, net of principal repayments
and $4.7 million in forgiven principal and accrued interest. Such loans bear
interest at rates per annum ranging from 5.81% to 7.5%, and are payable in full
on October 20, 1998, or earlier in the event certain revenues are received by
Genta Jago and specified cash balances are maintained by Genta Jago. There can
be no assurance, however, that Genta Jago will obtain the necessary financial
resources to repay such loans to Genta. The Company has recorded all of the net
losses incurred by Genta Jago as a reduction of the Company's investment in
joint venture or loans receivable from joint venture. Genta initially carried
the advances as "loans receivable from joint venture" until Genta Jago actually
spend the funds, since Genta believed it had the legal right to recover any
unexpended funds as a debt-holder. However, as the funds were spent by Genta
Jago, Genta was no longer assured of the collectibility of such loans, so the
carrying value was reduced accordingly as the offset to Genta's recognition of
its equity in the net loss of Genta Jago. Therefore, at all times Genta's
recorded asset "loans receivable from joint venture" never exceeded the amount
of Genta Jago's unexpended cash. Genta did not believe it was appropriate to
carry its investment in or loans receivable from Genta Jago at any amount in
excess of Genta Jago's cash, as there was no assurance of recoverability of such
additional amounts. Accordingly, Genta recognized 100% of the losses of Genta
Jago.
The Company is currently in negotiations with Jagotec and its affiliates
to reach an agreement under which the terms of the joint venture would be
restructured and future funding levels could be determined. There can be no
assurance that such negotiations will result in a mutually satisfactory
agreement.
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
In 1995, Genta Jago returned certain Anticode(TM) technology to Genta in
exchange for Genta's forgiveness of $4.7 million of principal and interest
outstanding under existing working capital loans to Genta Jago. This amount was
determined by an arm's length negotiation between Genta, Jagotec and Genta Jago
and was based on the amount actually expended by Genta Jago for research and
development related to such Anticode(TM) oligonucleotide technology from the
time Genta Jago originally acquired the relevant technology in 1992 through the
date of return in 1995. This forgiveness had no impact on Genta's financial
statements, as Genta had already expensed Genta Jago's expenditures of such
cash, and had no carrying value for the loans at the time of the forgiveness.
The forgiveness was treated by Genta Jago as a gain on the waiver of debt
because this reflected the legal form of the transaction.
Under terms of the joint venture, Genta Jago has contracted with the
Company to conduct research and development and provide certain other services.
Revenues associated with providing such services, totaled $2.7 million, $1.6
million and $350,000 for the years ended December 31, 1995, 1996 and 1997,
respectively. Terms of the arrangement also grant the Company an option to
purchase Jagotec's interest in Genta Jago exercisable from December 31, 1998
through December 31, 2000. See "Business--Genta Jago."
Genta Jago entered into collaborative development agreements with Gensia,
Inc., Apothecon, Inc., a subsidiary of Bristol-Myers Squibb Co., and Krypton,
Ltd., a subsidiary of SkyePharma, during January 1993, March 1996 and October
1996, respectively. Such agreements provide funding to Genta Jago for the
development and clinical testing of selected controlled-release pharmaceuticals
in addition to potential milestone payments and royalties on future product
sales. Effective October 1996, Gensia and SkyePharma reached an agreement
whereby a SkyePharma subsidiary, Brightstone Pharma, Inc. ("Brightstone"), was
assigned Gensia's rights (and those of Gensia's partner, Boehringer Mannheim) to
develop and co- promote the potentially bioequivalent nifedipine product under
the collaboration agreement with Genta Jago. The assignment was accepted by
Genta Jago and has no impact on the terms of the original agreement.
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
Condensed financial information for Genta Jago Technologies B.V. is set forth
below.
December 31,
1996 1997
-------------------------------
Balance Sheet Data:
Receivables under collaboration
agreements ............................... $ 904,000 $ 1,400,000
Other current assets ....................... 142,000 31,000
-------------------------------
Total current assets ....................... 1,046,000 1,431,000
Other assets ............................... 11,000 4,000
-------------------------------
$ 1,057,000 $ 1,435,000
===============================
Current liabilities ........................ $ 3,053,000 $ 5,213,000
Notes payable to Genta Incorporated ........ 15,287,000 15,837,000
Net capital deficiency ..................... (17,283,000) (19,615,000)
===============================
$ 1,057,000 $ 1,435,000
===============================
<TABLE>
<CAPTION>
Year Ended December 31,
1995 1996 1997
---------------------------------------------
<S> <C> <C> <C>
Statements of Operations Data:
Collaborative research and
development revenues ..................... $ 3,634,000 $ 5,477,000 $ 2,968,000
Costs and expenses ......................... 4,791,000 8,453,000 10,336,000
---------------------------------------------
Loss from operations ....................... (1,157,000) (2,976,000) (7,368,000)
Gain on waiver of debt in exchange for
return of license rights to related party -- -- 4,703,000
Interest expense ........................... (1,175,000) (956,000) (746,000)
---------------------------------------------
Net loss ................................... $ (2,332,000) $ (3,932,000) $ (3,411,000)
=============================================
</TABLE>
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
6. Intangibles
Intangibles consist of the following:
December 31,
1996 1997
-----------------------------
Purchased proprietary technology ........... $ 1,747,082 $ 1,747,082
Patent and patent applications ............. 2,964,193 2,605,539
Organizational and other amortizable
costs ................................... 414,521 414,521
-----------------------------
5,125,796 4,767,142
Less accumulated amortization .............. (1,103,554) (1,377,110)
-----------------------------
$ 4,022,242 $ 3,390,032
=============================
7. Notes Payable and Leases
Notes payable consist of the following:
December 31,
1996 1997
---------------------------
Note payable with interest at 12.63%, due in
monthly installments of $22,407, secured by
equipment; extinguished in 1997 through monthly
payments and application of $251,000 security
deposit to remaining principal balance .......... $ 328,367 $ --
Research financing obligation payable to a French
governmental agency, non- interest bearing,
maturing through 2002 ........................... 1,040,462 897,627
Other ........................................... 7,435 2,931
---------------------------
1,376,264 900,558
Less current portion ............................ (1,287,338) (900,558)
---------------------------
$ 88,926 $ --
===========================
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
During 1995, Genta Pharmaceuticals Europe S.A. ("Genta Europe") received
approximately $1,100,000 of funding in the form of a loan from the French
government agency L'Agence Nationale de Valorisation de la Recherche ("ANVAR")
towards research and development activities pursuant to an agreement (the "ANVAR
Agreement") between ANVAR, Genta Europe and Genta. In October 1996, as part of
the Company's restructuring program, Genta Europe terminated all scientific
personnel. ANVAR asserted, in a letter dated February 13, 1998, that Genta
Europe was not in compliance with the ANVAR Agreement, and that ANVAR might
request the immediate repayment of such loan. Accordingly, the Company has
included the ANVAR note payable in the current portion of notes payable in the
balance sheet. The Company does not believe that under the terms of the ANVAR
Agreement ANVAR is entitled to request early repayment and is working with ANVAR
to achieve a mutually satisfactory resolution. Contractual principal maturities
of notes payable for the years 1998 through 2002 are $86,000, $133,000,
$166,000, $332,000 and $184,000, respectively.
The Company leases its facilities under operating leases that generally
provide for annual cost of living related increases. The JBL facilities are
leased from its prior owners, who include a director, an executive officer and
other stockholders of the Company. Minimum future obligations under operating
leases at December 31, 1997 are as follows:
Operating Leases
---------------------------
Related
Parties Others
---------------------------
1998 .................................... $ 408,000 $ 131,000
1999 .................................... 429,000 99,000
2000 .................................... 188,000 99,000
2001 .................................... -- 99,000
2002 .................................... -- 99,000
Thereafter .............................. -- 99,000
---------------------------
Total future minimum less payments ...... $1,025,000 $ 626,000
===========================
Total rent expense under operating leases for the years ended December 31,
1995, 1996 and 1997 was $1,117,000, $1,043,000 and $774,000, respectively.
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
8. Stockholders' Equity
Common Stock
On April 4, 1997 the Board of Directors authorized, and the Shareholders
approved, a ten for one reverse stock split. All share and per share amounts and
stock option data have been restated to retroactively reflect the stock split.
In August 1997, 7,500 shares of common stock were issued to a former
Officer of the Company pursuant to the terms of a severance agreement. In
December 1997, 30,900 shares of common stock were issued to two former Board
Members of the Company pursuant to the terms of their consulting agreements.
Also in December 1997, 1,250 shares of common stock that had been previously
issued to a former Board Member were returned to the Company in exchange for the
forgiveness of a note receivable from such former Board Member.
Preferred Stock
In June 1997, the Company raised gross proceeds of approximately $16.2
million (approximately $14 million net of placement costs) through the private
placement of 161.58 Premium Preferred Units(TM). Each unit sold in the private
placement consists of 1,000 shares of Premium Preferred Stock(TM), par value
$.001 per share, stated value $100 per share (the "Series D Preferred Stock"),
and warrants to purchase 5,000 shares of the Company's common stock, (the "Class
D Warrants") at any time prior to the fifth anniversary of the final closing
(the "Class D Warrants"). The Series D Preferred Stock is immediately
convertible at the option of the holder into shares of common stock at an
initial conversion price of $0.94375 per share (subject to antidilution
adjustment). In addition, the holders of the Series D Preferred Stock sold in
the Private Placement are entitled to a liquidation preference aggregating
$31,779,300. Due to the increase in value associated with the discounted
conversion terms and liquidation preference of the Series D Preferred Stock, the
Company has accounted for such increase by charging $16,158,000 to dividends
imputed on preferred stock.
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
In February 1997, the Company raised gross proceeds of $3 million in a
private placement of Senior Secured Convertible Bridge Notes (the "Convertible
Notes") that bore interest at a stated rate of 12% (See Warrants) per annum and
matured on December 31, 1997, as extended, and warrants to purchase an aggregate
of approximately 6.4 million shares of common stock. The Convertible Notes were
convertible into Series D Convertible Preferred Stock at the option of the
holder, at an initial conversion price of $50.00 per share, subject to
antidilution adjustments. In May 1997, $650,000 of the Convertible Notes were
converted into 13,000 shares of Series D Preferred Stock and in December 1997,
the remaining $2,350,000 of the Convertible Notes and accrued interest were
converted into 52,415 shares of Series D Preferred Stock. Since it is unclear
that the bridge notes had any value as indebtedness, all of the $3.0 million was
allocated to the warrants. In addition, interest expense of $3.0 million plus
interest at the stated rate of 12% on the notes was recorded during the period
the notes were outstanding.
In September 1996, the Company raised gross proceeds of $2 million
(approximately $1.9 million net of offering costs) through the sale of
Convertible Debentures to investors in a private placement outside the United
States. The Convertible Debentures were convertible, at the option of the
holders, beginning in October 1996, into shares of common stock at a conversion
price equal to 75% of the average Nasdaq closing bid price of Genta's common
stock for a specified period prior to the date of conversion. Terms of the
Convertible Debentures also provided for interest payable in shares of the
Company's common stock. In November 1996, $1.65 million of the Convertible
Debentures and the related accrued interest was converted into approximately
590,000 shares of common stock and in 1997, the remaining $350,000 and related
accrued interest was converted into 204,263 shares of common stock. In April
1998, in consideration of the Emerging Issues Task Force Bulletin D-60,
"Accounting for the Issuance of Convertible Preferred Stock and Debt Securities
with a Nondetachable Conversion Feature" ("EITF D-60"), which was issued in
March 1997, the Company recorded non-cash imputed interest costs totaling
$666,667 in 1996 related to the discounted conversion terms. The Convertible
Debentures bore interest at an effective interest rate of 38% per annum.
In March 1996, the Company raised gross proceeds of $6 million
(approximately $5.5 million net of offering fees) through the issuance of Series
C Convertible Preferred Stock (the "Series C Preferred Stock") sold to
institutional investors in a private placement. The Series C Preferred Stock was
immediately convertible, at the option of the holder, into shares of common
stock at a conversion price equal to 75% of the average Nasdaq closing bid price
of Genta's common stock for a specified period prior to the date of conversion.
In 1996, 5,620 shares of the Series C Preferred Stock and accrued dividends were
converted at the option of the holders into 524,749 shares of Genta's common
stock. In 1997, 1,424 shares of the Series C Preferred Stock and accrued
dividends was converted at the option of the holders into 952,841 shares of
Genta's common stock. In April, 1998, in consideration of EITF D-60, which was
issued in March 1997, the Company recorded imputed non-cash dividends on
preferred stock totaling $2,348,000 in 1996 for discounted conversion terms
related to Series C convertible preferred stock
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
In December 1995, the Company completed the sale of 3,000 shares of Series
B Convertible preferred stock (the "Series B Preferred Stock") at a price of
$1,000 per share to institutional investors outside of the United States.
Proceeds from the offering totaling approximately $2.8 million were reflected as
a receivable from sale of preferred stock at December 31, 1995 and were received
by the Company on January 2, 1996. The Series B Preferred Stock was immediately
convertible, at the option of the holder, into shares of common stock at a
conversion price equal to 75% of the average Nasdaq closing bid prices of
Genta's common stock for a specified period prior to the date of conversion. The
Series B Preferred Stock was converted into 226,943 shares of the Company's
common stock in February 1996 pursuant to terms of the Series B stock purchase
agreements. In April, 1998, in consideration of EITF D-60, which was issued in
March 1997, the Company recorded imputed non-cash dividends on preferred stock
totaling $1.0 million in 1995 for discounted conversion terms related to Series
B convertible preferred stock.
In December 1993, the Board of Directors of the Company adopted a
Stockholder Rights Plan which provides for the distribution of a preferred stock
purchase right ("Right") as a dividend for each share of the Company's common
stock held of record at the close of business on January 21, 1994. Under certain
circumstances involving an acquisition of 15% or more of the Company's common
stock or a specified business combination, the Rights would permit the holder
(other than the 15% holder) to purchase shares of the Company's common stock or,
if applicable, common stock of an acquirer at a 50% discount upon payment of an
exercise price of $50 per Right. The Rights expire in December 2003 and may be
redeemed by the Company prior to a 15% acquisition at a price of $.01 per Right.
In October 1993, the Company completed the sale of 600,000 shares of
Series A convertible preferred stock ("the Series A Preferred Stock") in a
private placement of units consisting of one share of Series A Preferred Stock
and a warrant to acquire one share of common stock, sold at an aggregate price
of $50 per unit. Each share of Series A Preferred Stock is immediately
convertible, at any time prior to redemption, into shares of the Company's
common stock, at a rate determined by dividing the aggregate liquidation
preference of the Series A Preferred Stock by the conversion price. The
conversion price is subject to adjustment for antidilution. At December 31,
1997, each share of Series A Preferred Stock was convertible into 7.25 shares of
Common Stock.
Terms of the Company's Series A Preferred Stock require the payment of
dividends annually in amounts ranging from $3 per share per annum for the first
year to $5 per share per annum in the third and fourth years. Dividends may be
paid in cash or Common Stock or a combination thereof at the Company's option.
Dividends on the Series A Preferred Stock accrue on a daily basis (whether or
not declared) and shall accumulate to the extent not paid on the annual dividend
payment date following the dividend period for which they accrue.
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<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
The Company may redeem the Series A Preferred Stock under certain
circumstances, and was required to redeem the Series A Preferred Stock, subject
to certain conditions, in September 1996 at a redemption price of $50 per share,
plus accrued and unpaid dividends (the "Redemption Price"). The Company elected
to pay the Redemption Price in Common Stock in order to conserve cash and was
required under the terms of the Series A Preferred Stock to use its best efforts
to arrange for a firm commitment underwriting for the resale of such Common
Stock which would allow the holders ultimately to receive cash instead of
securities for their Series A Preferred Stock. Despite using its best efforts,
the Company was unable to arrange for a firm commitment underwriting. Therefore,
under the terms of the Series A Preferred Stock, Genta was not required to
redeem such Series A Preferred Stock in cash, but rather was required to redeem
all shares of Series A Preferred Stock held by holders who elected to waive the
firm commitment underwriting requirement and receive the redemption price in
shares of Common Stock. A waiver of the firm commitment underwriting was
included as a condition of such redemption. Through December 31, 1997, holders
of 143,400 shares of Series A Preferred Stock redeemed such shares and related
accrued and unpaid dividends for an aggregate of 774,188 shares of the Company's
Common Stock. The effect on the financial statements was a reduction in Accrued
dividends on preferred stock, a reduction in the Par value of convertible
preferred stock, an increase in the Par value of Common Stock, and an increase
in Additional paid-in capital. Should the remaining shares of Series A Preferred
stock be redeemed through conversion into the Company's Common Stock, the effect
on the financial statements will be the same as that previously described. The
terms of the Series A Preferred Stock do not impose adverse consequences on the
Company if it is unable to arrange for such an underwriting despite its
reasonable efforts in such regard.
The SEC Staff is currently in the process of reviewing a registration
statement filed by the Company, and has raised certain questions regarding the
Company's classification of the Preferred Stock as permanent (rather than
"mezzanine") equity. Management of the Company believes, based upon its
Certificate of Incorporation and the agreement pursuant to which the Preferred
Stock was issued, and after discussion with Company counsel, that the conditions
for redemption of the Preferred Stock require volitional acts undertaken by the
Company and are therefore solely within the control of the Company. If the SEC
Staff does not accept the Company's position, the Company will file an amendment
to this Form 10-K reclassifying the Preferred Stock as "mezzanine" rather than
permanent equity.
The Company is restricted from paying cash dividends on Common Stock until
such time as all cumulative dividends on outstanding shares of Series A and
Series D Preferred Stock have been paid. The Company currently intends to retain
its earnings, if any, after payment of dividends on outstanding shares of Series
A and Series D Preferred Stock, for the development of its business.
-85-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
Warrants
At December 31, 1997, warrants (the "Series A Warrants") to purchase an
aggregate of 675,966 shares of common stock, exercisable at $9.32 per share as
adjusted for the effect of anti-dilution provisions, were outstanding. The
Series A Warrants were originally issued in connection with the Series A
Preferred Stock in 1993. The Series A Warrants expire in September 1998 and are
subject to anti-dilution adjustments. The Company also issued a five-year
warrant to purchase 23,525 shares of common stock at an exercise price of $17.00
per share in connection with a private placement of common stock in May 1995. In
addition, five-year warrants to purchase an aggregate of 24,731 shares of common
stock at exercise prices ranging from $19.40 to $21.30 per share were issued to
two equipment financing companies during 1995. In October 1996, the Company
issued a five year warrant to purchase 37,512 shares of common stock at an
exercise price of $13.20 per share to a patent law firm, in exchange for legal
services. In October 1996, the Company also issued a five year warrant to
purchase 10,000 shares of common stock at an exercise price of $15.00 per share
in connection with the Convertible Debentures issued in September 1996. In
connection with the $3.0 million Convertible Notes issued in February 1997, the
Company issued warrants to purchase 6.4 million shares of common stock at
$0.471875 per share (subject to antidilution adjustments). In the absence of
objective evidence of the separate values of the Convertible Notes and the
related warrants, the Company allocated the entire cash consideration to the
warrants. The Convertible Notes were accreted from the original recorded value
of zero to the face amount of $3.0 million over the original maturity of the
Convertible Notes, resulting in $3.0 million of interest expense in 1997. In
1997, the Company issued warrants to purchase 50,000 warrants at $2.50 per share
exercisable for five years in connection with a short term line of credit which
expired prior to December 31, 1997. The Company valued these warrants using the
Black-Scholes valuation model and recorded interest expense of $98,000 for the
year ended December 31, 1997. In connection with the issuance of the Premium
Preferred Units(TM) in June 1997, the placement agent received warrants (the
"Placement Warrants") to purchase up to 10% of the Units sold in the Private
Placement for 110% of the offering price per Unit. Furthermore, the Company has
agreed to enter into a financial advisory agreement with the placement agent
pursuant to which the financial advisor shall receive certain cash fees and has
received warrants (the "Advisory Warrants") to purchase up to 15% of the Units
sold in the Private Placement for 110% of the offering price per Unit. The
Placement Warrants and the Advisory Warrants expire on June 29, 2007.
-86-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
Stock Benefit Plans
The Company's 1991 Stock Plan (the "Plan") provides for the sale of
stock and the grant of stock options to employees, directors, consultants and
advisors of the Company. Options may be designated as incentive stock options or
non-statutory stock options; however, incentive stock options may be granted
only to employees of the Company. Options under the Plan have a term of up to
ten years and must be granted at not less than the fair market value (85% of
fair market value for non-statutory options) on the date of grant. Common stock
sold and options granted pursuant to the Plan generally vest over a period of
four to five years. Information with respect to the Company's 1991 Stock Plan is
as follows:
Weighted
average
Shares under exercise price
option per share
-----------------------------
Balance at December 31, 1994 ................. 174,722 $78.12
Granted ..................................... 198,803 $23.55
Exercised ................................... (732) $ 5.00
Canceled .................................... (183,909) $73.09
---------------
Balance at December 31, 1995 ................. 188,884 $23.96
Granted ..................................... 13,677 $17.71
Exercised ................................... (7,882) $21.77
Canceled .................................... (29,749) $22.32
---------------
Balance at December 31, 1996 .................. 164,930 $23.77
Granted ..................................... 6,670 $ 3.71
Exercised ................................... -- $ --
Canceled .................................... (48,688) $23.21
---------------
Balance at December 31, 1997 ................. 122,912 $22.90
=============================
In April 1995, the Stock Plan Committee of the Board of Directors approved
a program whereby employees (including executive officers) of the Company and
certain other option holders could exchange their unexercised options ("Old
Options") on a one-for-one basis for new options ("New Options") priced at the
market value on April 20, 1995. The New Options have the same vesting schedule
and contractual terms as the Old Options. However, the New Options held by
employees (excluding executive officers) and certain other holders were not
exercisable until April 20, 1996 and the New Options held by executive officers
of the Company were not
-87-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
exercisable until April 20, 1997 unless the holder is involuntarily terminated
without cause prior to such date. An aggregate of 158,133 options with an
average exercise price of approximately $78.40 per share were exchanged for New
Options with an exercise price of $22.50 per share on April 20, 1995. All of the
replacement options are included in options granted and canceled in the above
summary of stock option activity.
At December 31, 1997, options to purchase approximately 109,552 shares of
common stock were exercisable at a weighted average price of approximately
$23.46 per share and approximately 155,602 shares of common stock were available
for grant or sale under the Plan. An aggregate of approximately 39,881,519
shares of common stock were reserved for the conversion of preferred stock and
the exercise of outstanding options and warrants at December 31, 1997.
Adjusted pro forma information regarding net loss is required by SFAS 123,
and has been determined as if the Company had accounted for its employee stock
options under the fair value method of that Statement. The fair value for these
options was estimated at the date of grant using the "Black Scholes" method for
option pricing with the following weighted-average assumptions for 1995, 1996
and 1997: volatility factors of the expected market value of the Company's
common stock of 70%, 80% and 102%, respectively; risk-free interest rates of 6%;
dividend yields of 0%; and a weighted-average expected life of the options of
five years.
For purposes of adjusted pro forma disclosures, the estimated fair value
of the options is amortized to expense over the options' vesting period. The
Company's adjusted pro forma information follows:
<TABLE>
<CAPTION>
Years Ended December 31,
1995 1996 1997
---------------------------------------------------
<S> <C> <C> <C>
Adjusted pro forma net less $ (29,027,475) $ (17,294,920) $ (33,493,186)
Adjusted pro forma loss per share $ (14.87) $ (5.80) $ (7.57)
</TABLE>
The results above are not likely to be representative of the effects of
applying SFAS 123 on reported net income or loss for future years as these
amounts reflect the expense for only one, two or three years vesting.
-88-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
The weighted-average grant-date fair value of the options granted during
the years ended December 31, 1995, 1996 and 1997 was $8.22, $11.59 and $2.75,
respectively. Following is a further breakdown of the options outstanding as of
December 31, 1997:
<TABLE>
<CAPTION>
Weighted
average
Weighted Weighted exercise price
average average of
Range Options remaining exercise Options options
of prices outstanding life in years price exercisable exercisable
- -------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
$3.13 - $5.00 13,368 6.06 $ 4.27 6,939 $ 3.89
$5.01 -$19.99 6,537 8.56 14.77 3,714 16.90
$20.00 -$75.00 103,007 7.27 25.02 98,899 25.08
-------------------------------------------------------------
122,912 7.21 $ 22.90 109,552 $ 23.46
=============================================================
</TABLE>
9. Research, Development and Licensing Arrangements
The Company entered into a collaborative research and development
agreements with The Procter & Gamble Company ("P&G") during 1991. The agreement
generally provided for the Company to receive research funding for the discovery
and development of specified Anticode products. The P&G collaboration, as
extended and modified, ended in September 1995. Collaborative revenues of $1.1
million were recognized under this contract during 1995, which amount
approximates costs incurred on the programs.
In addition to the aforementioned arrangement, the Company has entered
into various license, royalty and sponsored research agreements which provide
the Company with rights to develop and market products covered under the
agreements. In connection with certain license agreements entered into with a
director of the Company and two other stockholders, the Company recorded royalty
expense of $100,000, $100,000 and $87,500 in 1995, 1996 and 1997, respectively.
The Company was not obligated to repay any funding received under the
collaborative research and development agreements under any circumstances.
10. Income Taxes
Significant components of the Company's deferred tax assets as of December
31, 1996 and 1997 are shown below. A valuation allowance of $36,456,000 has been
recognized to
-89-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
offset the deferred tax assets as it is more likely than not that the net
deferred tax assets will not be realized.
1996 1997
-------------------------------
Deferred tax assets:
Capitalized research expense ............. $ 2,663,000 $ 2,778,000
Net operating loss carryforwards ......... 22,177,000 25,969,000
Research and development credits ......... 3,248,000 3,703,000
Purchased technology and license fees .... 4,523,000 4,491,000
Other, net ............................... 1,108,000 497,000
-------------------------------
Total deferred tax assets ................ 33,719,000 37,438,000
Valuation allowance for deferred tax
assets ................................. `(32,508,000) (36,456,000)
-------------------------------
1,211,000 982,000
Deferred tax liabilities:
Patent expenses .......................... (1,211,000) (729,000)
Net depreciation ......................... -- (253,000)
-------------------------------
(1,211,000) (982,000)
-------------------------------
Net deferred tax assets .................... $ -- $ --
===============================
At December 31, 1997, the Company has federal and California net operating
loss carryforwards of approximately $71,697,000 and $15,236,000, respectively.
The difference between the federal and California tax loss carryforwards is
primarily attributable to the capitalization of research and development
expenses for California tax purposes and the fifty percent limitation on
California loss carryforwards prior to 1997. The federal tax loss carryforwards
will begin expiring in 2003, unless previously utilized. Approximately
$2,767,000 of the California tax loss carryforward expired during 1997 and the
related deferred tax asset and tax loss carryforward amounts have been reduced
accordingly. The remaining California tax loss will continue to expire in 1998,
unless utilized. The Company also has federal and California research and
development tax credit carryforwards of $2,921,000 and $1,203,000, respectively,
which will begin expiring in 2003 unless previously utilized.
Federal and California tax laws limit the utilization of income tax net
operating loss and credit carryforwards that arise prior to certain cumulative
changes in a corporation's ownership resulting in change of control of the
Company. The future annual use of net operating loss carryforwards and research
and development tax credits will be limited due to the ownership changes that
occurred during 1990, 1991, 1993, 1996 and 1997. Because of the decrease in
value of the Company's stock, the ownership changes which occurred in 1996 and
1997, will have a material adverse impact on the Company's ability to utilize
these
-90-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
carryforwards. See "Market for Registrant's Common Equity and Related
Stockholder Matters--Recent Sales of Unregistered Securities."
11. Employee Savings Plan
The Company began a 401(k) program in 1994 which allowed participating
employees to contribute up to 15% of their salary, subject to annual limits. In
January 1998, the Board of Directors approved an increase to 20%, effective
April 1, 1998, and subject to annual limits as established by the IRS. The Board
of Directors may, at its sole discretion, approve Company contributions. No such
contributions have been approved or made.
12. Employee Terminations
As noted above, in an effort to reduce costs and conserve working capital,
Genta initiated a termination plan in March 1995, whereby the Company terminated
26 employees involved in the Company's research and development activities. The
Company recorded General and Administrative expenses totaling $250,000 for
accrued severance costs associated with the 26 terminated employees. In October
1996, Genta again reassessed its personnel requirements and established a second
termination plan whereby the Company terminated 16 research and administrative
employees and recorded General and Administrative expenses of $850,000 for
accrued severance. In May 1997, Genta again reassessed its personnel
requirements and established a third termination plan involving the termination
of an aggregate of 12 research and administrative employees at Genta and Genta
Europe. The Company recorded General and Administrative expenses of $868,000 in
the second quarter of 1997 for accrued severance costs. There were no
adjustments to the liabilities recorded and actual termination benefits paid
were equal to the liabilities recorded.
13. Contingencies
LBC Capital Resources, Inc. ("LBC"), a Philadelphia-based broker/dealer,
has asserted claims against the Company and others. LBC's claims relate to the
alleged breach by the Company of certain letter agreements, allegedly entered
into by LBC and the Company in 1995 and 1996 with respect to brokerage and/or
investment banking services particularly in connection with a $3 million
investment for which LBC is seeking a fee. On March 30, 1998, the Company
received a Statement of Claim under NASD arbitration rules, and a request that
the Company voluntarily submit to NASD arbitration. The Company has not yet
responded to that request. LBC's Statement of Claim seeks damages in the form of
cash (in excess of $4 million), stock, warrants and other securities. On April
9, 1998, the Company's counsel learned that, in addition, a Complaint has been
filed in the United States District Court for the Southern District of New York
(98 Civ. 2491) by LBC against the Company and the same
-91-
<PAGE>
Genta Incorporated
Notes to Consolidated Financial Statements (continued)
other parties. However, such Complaint has not yet been served upon the Company.
The Company believes it has valid legal and equitable defenses to LBC's claim.
Whether LBC's claims are ultimately adjudicated in arbitration or litigation,
the Company intends to defend vigorously and possibly to assert counterclaims
against LBC.
In October 1996, JBL retained a chemical consulting firm to advise it with
respect to an incident of soil and groundwater contamination (the "Spill").
Sampling conducted at the JBL facility revealed the presence of chloroform and
perchloroethylenes ("PCEs") in the soil and groundwater at this site. Six soil
borings were drilled and groundwater wells were installed at several locations
around the site. Chloroform was detected at levels of up to 190 ug/liter
on-site, exceeding the California Drinking Water Maximum Contamination Level for
trihalomethanes of 100 ug/liter. PCEs were also detected at levels of up to 22
ug/liter on- site, exceeding the California Drinking Water Maximum Contamination
Level of 5 ug/liter. In addition, Toluene was detected at levels of up to 2
ug/liter at several points on-site, which is significantly below the California
Toxicity Action Level of 100 ug/liter. These toxicity levels are not binding, as
the final regulatory maximum levels may be higher or lower. JBL has notified the
appropriate regulatory agency, the California Regional Water Quality Control
Board, of conditions at the site, and with the agency's approval, JBL is
monitoring groundwater conditions at the site on a quarterly basis. JBL is
currently in the pre-regulatory action stage with ongoing site monitoring and
site assessment. In addition, current sampling results indicate that
contaminants may be migrating off-site. An off-site well, used as a domestic and
irrigation water source, has shown evidence of being impacted by chloroform at
0.9 ug/liter, significantly below (less than one percent of) the California
Drinking Water Maximum Contamination Level for trihalomethanes of 100 ug/liter,
and toluene at 0.9 ug/liter, also significantly below (less than one percent of)
the California Toxicity Action Level of 100 ug/liter. While another off-site
well has been found to contain chloroform, the engineering consultant concluded
that the contaminants do not appear to relate to impact from the JBL site. The
Company believes that any costs associated with further investigating or
remediating this contamination will not have a material adverse effect on the
business of the Company, although there can be no assurance thereof.
14. Genta Europe
The Company's loss on its European operations for the years ended December
31, 1995, 1996 and 1997 were $1,266,531, $1,247,713 and $806,687, respectively.
15. Gain on Sale of Technology
In December 1996, the Company sold the rights to two development-stage
dermatological products for cash of $373,261.
-92-
<PAGE>
Report of Ernst & Young LLP, Independent Auditors
The Board of Directors and Stockholders
Genta Jago Technologies B.V.
We have audited the accompanying balance sheets of Genta Jago Technologies B.V.
(a development stage company) as of December 31, 1996 and 1997, and the related
statements of operations, stockholders' equity (net capital deficiency) and cash
flows for each of the three years in the period ended December 31, 1997 and for
the period December 15, 1992 (inception) through December 31, 1997. These
financial statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Genta Jago Technologies B.V. (a
development stage company) at December 31, 1996 and 1997, and the results of its
operations and its cash flows for each of the three years in the period ended
December 31, 1997, and for the period December 15, 1992 (inception) through
December 31, 1997, in conformity with generally accepted accounting principles.
As discussed in Note 1 to the financial statements, the Company has incurred
operating losses since inception and requires substantial sources of financing
to fund its operations through 1998. These conditions raise substantial doubt
about the Company's ability to continue as a going concern. The 1997 financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
San Diego, California
April 13, 1998
-93-
<PAGE>
Genta Jago Technologies B.V.
(a development stage company)
Balance Sheets
December 31,
Assets 1996 1997
---------------------------
Current assets:
Cash and cash equivalents ........................ $ 36,092 $ 9,247
Receivables under collaboration agreements ....... 903,838 1,399,854
Other current assets ............................. 105,934 22,246
---------------------------
Total current assets ............................... 1,045,864 1,431,347
Property and equipment, net ....................... 4,900 2,300
Other assets ....................................... 6,651 1,672
---------------------------
$ 1,057,415 $ 1,435,319
===========================
Liabilities and net capital deficiancy
Current liabilities:
Accounts payable and accrued expenses ............ $ 571,539 $ 1,792,293
Payable to related parties ....................... 2,481,452 3,420,456
---------------------------
Total current liabilities .......................... 3,052,991 5,212,749
Notes payable to Genta Incorporated ................ 15,287,099 15,837,099
Stockholders' equity (net capital deficiency):
Common Stock, 14,700 shares authorized,
10,000 shares issued and outstanding
at stated value ................................ 512,000 512,000
Additional paid-in capital ....................... 3,741,950 3,741,950
Deficit accumulated during the development stage . (21,536,625) (23,868,479)
---------------------------
Net capital deficiency ............................. (17,282,675) (19,614,529)
---------------------------
$ 1,057,415 $ 1,435,319
===========================
See accompanying notes
-94-
<PAGE>
Genta Jago Technologies B.V.
(a development stage company)
Statements of Operations
<TABLE>
<CAPTION>
Cumulative
from December
15, 1992
(inception)
through
Years ended December 31, December 31,
Revenues: 1995 1996 1997 1997
-------------------------------------------------------------
<S> <C> <C> <C> <C>
Collaborative research and
development $ 2,968,463 $ 5,477,059 $ 3,634,516 $ 19,040,894
Cost and expenses:
Research and development,
including contractual amounts to
related parties of $9,318,460, $7,040,438,
and $4,540,067, and $40,169,225 in 1995,
1996 and 1997 and the period from
December 15, 1992 (inception) to
December 31, 1997, respectively 9,866,038 8,091,465 4,740,299 43,003,883
General and administrative 470,081 361,920 50,869 1,436,252
-------------------------------------------------------------
10,336,119 8,453,385 4,791,168 44,440,135
-------------------------------------------------------------
Loss from operations (7,367,656) (2,976,326) (1,156,652) (25,399,241)
Other income (expense):
Gain on waiver of debt in exchange for
return of license rights to related party 4,703,352 -- -- 4,703,352
Interest income 2,620 5,814 209 19,755
Interest expense (749,808) (961,075) (1,175,411) (3,192,345)
-------------------------------------------------------------
3,956,164 (955,261) (1,175,202) 1,530,762
-------------------------------------------------------------
Net loss $ (3,411,492) $ (3,931,587) $ (2,331,854) $(23,868,479)
=============================================================
</TABLE>
See accompanying notes
-95-
<PAGE>
Genta Jago Technologies B.V.
(a development stage company)
Statement of Stockholders' Equity (Net Capital Deficiency)
December 15, 1992 (inception) to December 31, 1997
<TABLE>
<CAPTION>
Deficit
accumulated Stockholders'
Common stock Additional during the equity (net
------------------------------------------ development capital
shares amount paid-in capital stage deficiency)
----------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Issuance of common stock at $51.20 per share
for cash ................................. 2,940 $ 150,528 $ -- $ -- $ 150,528
Capital contributions in excess
of stated value ............................. -- -- 12,882 -- 12,882
----------------------------------------------------------------------
Balance at December 31, 1992 .................. 2,940 150,528 12,882 -- 163,410
Issuance of common stock at $51.20 per share
for cash ................................. 7,060 361,472 -- -- 361,472
Capital contributions in excess of stated value -- -- 3,729,068 -- 3,729,068
Net Loss ...................................... -- -- -- (5,842,165) (5,842,165)
----------------------------------------------------------------------
Balance at December 31, 1993 .................. 10,000 512,000 3,741,950 (5,842,165) (1,588,215)
Net Loss ...................................... -- -- -- (8,351,381) (8,351,381)
----------------------------------------------------------------------
Balance at December 31, 1994 .................. 10,000 512,000 3,741,950 (14,193,546) (9,939,596)
Net Loss ...................................... -- -- -- (3,411,492) (3,411,492)
----------------------------------------------------------------------
Balance at December 31, 1995 .................. 10,000 512,000 3,741,950 (17,605,038) (13,351,088)
Net Loss ...................................... -- -- -- (3,931,587) (3,931,587)
----------------------------------------------------------------------
Balance at December 31, 1996 .................. 10,000 512,000 3,741,950 (21,536,625) (17,282,675)
Net Loss ...................................... -- -- -- (2,331,854) (2,331,854)
----------------------------------------------------------------------
Balance at December 31, 1997 .................. 10,000 $ 512,000 $ 3,741,950 $(23,868,479) $(19,614,529)
======================================================================
</TABLE>
See accompanying notes.
-96-
<PAGE>
Genta Jago Technologies B.V.
(a development stage company)
Statements of Cash Flows
<TABLE>
<CAPTION>
Cumulative
from December
15, 1992
(inception) to
Years ended December 31, December 31,
1995 1996 1997 1997
-------------------------------------------------------------
<S> <C> <C> <C> <C>
Operating Activities
Net Loss ...................................... $ (3,411,492) $ (3,931,587) $ (2,331,854) $(23,868,479)
Items reflected in net loss not requiring cash:
Depreciation and amortization ................. 2,600 2,600 2,600 15,768
Technology license fee ........................ -- -- -- 192,580
Gain on waiver of debt in exchange for
return of license rights to related party (4,703,352) -- -- (4,703,352)
Changes in operating assets and liabilities:
Advance contract payments to related
parties ............................... 435,276 1,538,594 -- --
Receivables under collaboration
agreements ............................ -- (903,838) (496,016) (1,399,854)
Other current assets ..................... 68,440 (105,934) 83,688 (22,246)
Accounts payable and accrued expenses .... 112,227 324,185 1,220,754 1,792,293
Payable to related parties ............... 277,479 1,686,614 939,004 3,420,456
Deferred contract revenue ................ (1,071,863) (317,555) -- --
----------------------------------------------- ------------
Net cash used in operating activities ......... (8,290,685) (1,706,921) (581,824) (24,572,834)
Investing Activities
Purchase of property and equipment and
other ..................................... (4,492) (2,159) 4,979 (19,740)
----------------------------------------------- ------------
Net cash provided by (used in) investing
activities ................................ (4,492) (2,159) 4,979 (19,740)
Financing Activities
Proceeds from issuance of common stock
and capital contributions ................. -- -- -- 4,061,370
Proceeds from notes payable to related party .. 8,415,407 1,500,000 550,000 21,140,643
Repayment of notes payable to related party ... -- -- -- (600,192)
----------------------------------------------- ------------
Net cash provided by financing activities ..... 8,415,407 1,500,000 550,000 24,601,821
----------------------------------------------- ------------
Increase (decrease) in cash and cash
equivalents ............................... 120,230 (209,080) (26,845) 9,247
Cash and cash equivalents at beginning of
period .................................... 124,942 245,172 36,092 --
----------------------------------------------- ------------
Cash and cash equivalents at end of period .... $ 245,172 $ 36,092 $ 9,247 $ 9,247
=============================================== ============
Supplemental disclosure of cash flow
information:
=============================================== ============
Interest paid ................................. $ -- $ -- $ -- $ 299,808
=============================================== ============
</TABLE>
See accompanying notes.
-97-
<PAGE>
Genta Jago Technologies B.V.
(a development stage company)
Notes to Financial Statements
December 31, 1997
1. Organization and Significant Accounting Policies
Organization and Business
Genta Jago Technologies B.V. ("Genta Jago") was incorporated in December
1992 under the laws of the Netherlands. Genta Jago is a joint venture owned and
controlled 50% by Genta Incorporated ("Genta") and 50% by Jagotec AG
("Jagotec"), a subsidiary of Jago Holding AG which was acquired by SkyePharma in
May 1996. Genta Jago was formed to develop and commercialize pharmaceuticals in
six major therapeutic areas, and commenced research and development activities
in January 1993. Genta Jago is managed under the direction of a Board of
Managing Directors consisting of two members appointed from each of Genta and
Jagotec and one outside member.
In connection with the formation of the joint venture in 1992, Genta
obtained from Jagotec and subsequently contributed to Genta Jago an exclusive
license to GEOMATRIX oral controlled-release technology for the development and
commercialization of approximately 25 specified products. In May 1995, Genta and
Jagotec entered into an agreement to expand Genta Jago by adding the rights to
develop and commercialize an additional 35 products (see "Expansion of Genta
Jago"). Genta Jago maintains the rights to develop and to commercialize
controlled-release formulations of approximately 60 products using Jagotec's
GEOMATRIX technology.
Genta Jago is dependent on future funding from Genta (see Note 2, "Capital
Contributions and Working Capital Agreement") and corporate partners and is
considered a development stage company. Genta has incurred significant operating
losses since inception and expects that they will continue for the next several
years. These conditions raise substantial doubt about the Company's ability to
continue as a going concern.
Revenue Recognition
Collaborative research and development revenues are recorded as earned as
research and development activities are performed under the terms of the
contracts, with such revenues generally approximating costs incurred on the
programs. Payments received in excess of amounts earned are deferred.
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Genta Jago Technologies B.V.
(a development stage company)
Notes to Financial Statements
December 31, 1997
Research and Development Expenses
Research and development costs are expensed as incurred.
Depreciation
The costs of furniture and equipment are depreciated over the estimated
useful lives of the assets using the straight-line method.
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities at the
date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ materially
from those estimates.
Recently Issued Accounting Standards
In June 1997, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standard No. 130, Reporting Comprehensive Income ("SFAS No.
130"). SFAS No. 130 requires that all components of comprehensive income,
including net income, be reported in the financial statements in the period in
which they are recognized. Comprehensive income is defined as the change in
equity during the period from transactions and other events and circumstances
from non-owner sources. Net income and other comprehensive income, including
unrealized gains and losses on investments, shall be reported, net of their
related tax effect, to arrive at comprehensive income. The Company does not
believe that comprehensive income or loss has been materially different than net
income or loss.
2. Related Party Transactions
License Agreements
Genta Jago entered into license agreements with Genta in connection with
the planned development and commercialization of GEOMATRIX oral
controlled-release products and Anticode(TM) oligonucleotide products. The
license with Genta in relation to the Anticode(TM) oligonucleotide products was
terminated in 1995, however, the license in
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<PAGE>
Genta Jago Technologies B.V.
(a development stage company)
Notes to Financial Statements
December 31, 1997
relation to the GEOMATRIX oral controlled-release products with Jagotec was not
terminated. Pursuant to such agreements, Genta Jago recorded license fee expense
of $85,000, $620,000 and $85,000 during the years ended December 31, 1995, 1996
and 1997, respectively.
Research and Development and Service Agreements
Genta Jago has contracted with Genta and Jagotec to conduct research and
development and provide certain other services. Under terms of such agreements,
Genta Jago generally is required to reimburse the parties for their respective
costs incurred plus a specified mark-up. Payments for research and development
services are generally made in advance and are refundable if the services are
not performed. For the years ended December 31, 1995, 1996 and 1997, Genta Jago
incurred expenditures of $9.3 million, $7 million and $4.5 million,
respectively, pursuant to such research and development and service agreements.
Capital Contributions and Working Capital Agreement
In connection with the formation of the joint venture, Genta contributed
$4 million in cash to Genta Jago as well as the rights to apply its Anticode(TM)
oligonucleotide technology to six products and also contributed the Initial
License referred to below. Genta issued 120,000 shares of Common Stock valued at
$7.2 million to Jagotec in 1992 as consideration for a license (the "Initial
License") for Genta to use Jagotec's GEOMATRIX technology with respect to
approximately 25 products, under the condition that Genta then contribute such
technology to Genta Jago, which Genta did. In addition, Genta Jago entered into
a working capital agreement with Genta which expires in October 1998. See
"MD&A--Liquidity and Capital Resources." Pursuant to this agreement, Genta is
required to make working capital loans to Genta Jago up to a mutually agreed
upon maximum principal amount, which amount is established by Genta and Genta
Jago not less than once each calendar quarter, if necessary, based upon the
review and consideration by the parties of mutually-acceptable budgets, expense
reports, forecasts and workplans for research and development of the products by
Genta Jago. Genta is not required to fund amounts in excess of the agreed-upon
commitment amount. Working capital loans consist of cash advances to Genta Jago
from Genta and research expenses incurred by Genta on behalf of Genta Jago. As
of December 31, 1997, Genta had advanced working capital loans of approximately
$15.8 million to Genta Jago, net of principal repayments and the loan credit
discussed below. Such loans bear interest at rates per annum ranging from 5.81%
to 7.5%, and are payable in full on October 20, 1998, or earlier in the event
certain revenues are received by Genta Jago and specified cash balances are
maintained by Genta Jago.
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Genta Jago Technologies B.V.
(a development stage company)
Notes to Financial Statements
December 31, 1997
Expansion of Genta Jago
In 1995, Genta obtained from Jagotec and subsequently contributed to Genta
Jago the rights to develop and commercialize an additional 35 products (the
"Additional Products") using Jagotec's GEOMATRIX technology. With these
Additional Products, Genta Jago now maintains the rights to develop
controlled-release formulations of approximately 60 products using Jagotec's
GEOMATRIX technology. Genta Jago is required to pay certain additional fees to
Jagotec upon Genta Jago's receipt of revenues from third parties, and pay
manufacturing royalties to Jagotec.
Return of Anticode(TM) Antisense License
Also in 1995, the parties elected to focus Genta Jago's activities
exclusively on GEOMATRIX oral-controlled release products. As a result, Genta
Jago returned to Genta the rights to develop six Anticode(TM) Oligonucleotide
products originally licensed from Genta in connection with the formation of
Genta Jago in 1992. In connection with the return of the Anticode(TM)
Oligonucleotide license rights to Genta in May 1995, Genta Jago's note payable
to Genta was credited with a principal reduction of approximately $4.4 million
and accrued interest payable to Genta was reduced by approximately $300,000.
Genta Jago recorded the loan credit and related accrued interest as a gain on
waiver of debt in exchange for return of license rights to Genta, based on the
legal structure of the transaction.
3. COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
Genta Jago/Gensia/Brightstone. In January 1993, Genta Jago entered into a
collaboration agreement with Gensia for the development and commercialization of
certain oral controlled-release pharmaceutical products for treatment of
cardiovascular disease. Under the agreement, Gensia provides funding for
formulation and preclinical development to be conducted by Genta Jago and is
responsible for clinical development, regulatory submissions and marketing.
Terms of the agreement provide Gensia exclusive rights to market and distribute
the products in North America, Europe and certain other countries. The agreement
has a term of the longer of twelve years and the patent term in the respective
countries within the territory. Genta Jago received $1.2 million, $2.2 million
and $1.9 million of funding in 1997, 1996 and 1995, respectively, pursuant to
the agreement. Collaborative revenues of $1.5 million, $2.8 million and $3
million were recognized under the agreement during the years ended December 31,
1997, 1996 and 1995, respectively. Effective October 1996, Gensia and SkyePharma
reached an
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Genta Jago Technologies B.V.
(a development stage company)
Notes to Financial Statements
December 31, 1997
agreement whereby a SkyePharma subsidiary, Brightstone Pharma, Inc.
("Brightstone"), was assigned Gensia's rights (and those of Gensia's partner,
Boehringer Mannheim) to develop and co-promote the potentially bioequivalent
nifedipine product under the collaboration agreement with Genta Jago. The
assignment was accepted by Genta Jago and has no impact on the terms of the
original agreement. Genta Jago is still entitled to receive additional milestone
payments from Brightstone triggered upon regulatory submissions and approvals,
as well as royalties or profit sharing ranging from 10% to 21% of product sales,
if any.
Genta Jago/Apothecon. In March 1996, Genta Jago entered into a
collaborative licensing and development agreement (the "Genta Jago/Apothecon
Agreement") with Apothecon, Inc. ("Apothecon"). Under the terms of the Genta
Jago/Apothecon Agreement, Apothecon will provide funding to Genta Jago up to a
specified maximum amount for the formulation of Q-CR ketoprofen (Oruvail(R)).
The Genta Jago/Apothecon Agreement expires upon the expiration of the relevant
patents in each covered country subject to certain early termination rights. The
agreement also provides for Genta Jago to receive potential milestone payments
and royalties on product sales. Terms of the agreement provide Apothecon
exclusive rights to market and distribute the products on a worldwide basis.
Genta Jago/Krypton. In October 1996, Genta Jago entered into five
collaborative licensing and development agreements (the "Genta Jago/Krypton
Agreements") with Krypton, Ltd. ("Krypton"), a subsidiary of SkyePharma, whereby
Genta Jago would sublicense to Krypton rights to develop and commercialize
potentially bioequivalent GEOMATRIX(R) versions of five currently marketed
products, as well as another agreement granting Krypton an option to sublicense
rights to develop and commercialize an improved version of a sixth product. The
Genta Jago/Krypton Agreements have terms of the shorter of fifteen years from
first commercial sale and the expiration of the patent term on a
territory-by-territory basis. During 1997, Genta Jago received funding of $1.9
million under the Genta Jago/Krypton Agreements and recognized $2.3 million of
collaborative revenue therefrom.
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<PAGE>
4. Income Taxes
Significant components of Genta Jago's deferred tax assets as of December
31, 1997 are shown below. A valuation allowance of $2,387,000 has been
recognized to offset the deferred tax assets as it is more likely than not that
the net deferred tax assets will not be realized.
December 31,
1996 1997
---------------------------------
Deferred tax assets:
Net operating loss carryforwards $ 2,154,000 $ 2,387,000
Valuation allowance for deferred tax assets (2,154,000) (2,387,000)
---------------------------------
Net deferred tax assets $ -- $ --
=================================
At December 31, 1997, Genta Jago has foreign net operating loss
carryforwards of approximately $23,868,000. The foreign tax loss carryforwards
will begin expiring in 2000, unless previously utilized.
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<PAGE>
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
Not Applicable.
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<PAGE>
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
(a) The sections labeled "Proposal Two--Election of Directors" and
"Section 16(a) Beneficial Ownership Reporting Compliance" appearing in the
Company's Proxy Statement are incorporated herein by reference.
(b) Information concerning the Company's Executive Officers is set
forth in Part I of this Form 10-K/A.
ITEM 11. EXECUTIVE COMPENSATION
The section labeled "Compensation of Executive Officers and
Directors" appearing in the Company's Proxy Statement is incorporated herein by
reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The section labeled "Stock Ownership of Management and Certain
Beneficial Owners" appearing in the Company's Proxy Statement is incorporated
herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The section labeled "Certain Relationships and Related Transactions"
appearing in the Company's Proxy Statement is incorporated herein by reference.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) (1) Financial statements
Reference is made to the Index to Financial Statements under Item 8 of this
report on Form 10-K/A.
(2) All schedules are omitted because they are not required, are
not applicable, or the required information is included in the
consolidated financial statements or notes thereto.
(3) Reference is made to Paragraph (c) below for Exhibits required
by Item 601 of Regulation S-K, including management contracts
and compensatory plans and arrangements.
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<PAGE>
(b) Reports on Form 8-K. During the fourth quarter of 1997, the Company
filed the following reports on Forms 8-K:
(i) On November 17, 1997, the Company filed a report on Form 8-K
dated November 14, 1997 reporting under Item 5 that the
Company issued a press release entitled "Genta Incorporated
Announces Third Quarterly 1997 Results.
(ii) On December 3, 1997, the Company filed a report on Form 8-K
dated December 3, 1997 reporting under Item 5 that the Company
issued a press release entitled "Genta Announces Initiation of
Phase I/II a Prostate Cancer Trial at Memorial Sloan-Kettering
Cancer Center."
(c) Exhibits required by Item 601 of Regulation S-K with each management
contract, compensatory plan or arrangement required to be filed
identified.
Exhibit
Number Description of Document
- ------ -----------------------
3(i).1(1) Restated Certificate of Incorporation as amended by the
Certificate of the Powers, Designations, Preferences and
Rights of the Series B Convertible Preferred Stock as
amended by the Certificate of the Powers, Designations,
Preferences and Rights of the Series C Convertible
Preferred Stock.
3(i).2(18) Certificate of Designations of Series D Convertible
Preferred Stock of the Company.
3(ii).1(2) By-laws of the Company.
3(ii).2(21) By-laws of the Company, as amended and restated September
23, 1997.
4.1(5) Specimen Common Stock Certificate.
4.2(4) Specimen Series A Convertible Preferred Stock Certificate.
4.3(4) Specimen Warrant.
4.4(4) Form of Unit Purchase Agreement dated as of September 23,
1993 by and between the Company and the Purchasers of the
Series A Convertible Preferred Stock and Warrants.
4.5(11) Form of Rights Agreement dated as of December 16,
1993 between Genta Incorporated and First Interstate Bank
of
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<PAGE>
California, which includes as Exhibit A the form of
Certificate of Designations, Rights and Preferences of
Series F Participating Preferred Stock.
4.6(8) Form of Regulation S Subscription Agreement entered into
between the Company and certain purchasers of the Series B
Convertible Preferred Stock.
4.7(1) Form of Securities Subscription Agreement entered into
between the Company and certain purchasers of the Series C
Convertible Preferred Stock.
4.8(1) Common Stock Purchase Warrant dated December 14, 1995
between the Company and Lease Management Services, Inc.
4.9(17) Warrant for the Purchase of 213,415 Shares of Common Stock
issued to Lyon & Lyon in October 1996.
4.10(17) Warrant for the Purchase of 100,000 Shares of Common Stock
issued to Michael Arnouse in October 1996.
10.1(3)(6)(6) Amended and Restated 1991 Stock Plan of Genta
Incorporated.
10.2(5) Master Lease Agreement No. 10300 dated as of May 4, 1989
between the Company and Lease Management Services, Inc.
and Master Lease Agreement No. 10428 dated as of August
15, 1991 between the Company and Lease Management
Services, Inc.
10.3(5) Standard Industrial Lease dated October 24, 1988, as
amended, between the Company and General Atomics.
10.4(5) Revised and Restated Lease dated as of March 1, 1990
between JBL Scientific, Inc. and Granada Associates.
10.5(5)(6) Employment Agreement dated February 20, 1991 between the
Company and Dr. Robert E. Klem.
10.6(5)(6) Employment Agreement dated February 20, 1991 between the
Company and Dr. Lauren R. Brown.
10.7(5)(6) Form of Indemnification Agreement entered into between the
Company and its directors and officers.
10.8(5) Preferred Stock Purchase Agreement dated September 30,
1991 and Amendment Agreement dated October 2, 1991.
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<PAGE>
10.9(5)(6) Consulting Agreement dated February 2, 1989 between the
Company and Dr. Paul O.P. Ts'o.
10.10(5)(7) Development, License and Supply Agreement dated February
2, 1989 between the Company and Gen-Probe Incorporated.
10.12(5)(7) License Agreement dated February 2, 1989 among the
Company, Dr. Ts'o, Dr. Miller and Mr. Finch.
10.13(5)(7) License Agreement dated May 15, 1990 between the Company
and The Johns Hopkins University.
10.19(6)(1) Promissory Note dated March 7, 1996 between the Company
and Dr. Donald Picker.
10.21(7)(9) Common Stock Transfer Agreement dated as of December 15,
1992, between the Company and Dr. Jacques Gonella.
10.32(9) Consulting Agreement dated as of December 15, 1992,
between the Company and Dr. Jacques Gonella.
10.36(7)(9) Common Stock Transfer Agreement dated as of December 15,
1992, between the Company and Jagotec AG.
10.37(7)(9) Collaboration Agreement dated as of January 22, 1993,
between Jobewol Investments B.V. (now known as Genta Jago
Technologies B.V.) and Gensia, Inc.
10.46(10) Form of Purchase Agreement between the Company and certain
purchasers of Common Stock.
10.47(10) Common Stock Purchase Warrant dated May 8, 1995 between
the Company and Index Securities S.A.
10.48(7)(12) Restated Joint Venture and Shareholders Agreement dated as
of May 12, 1995 between the Company, Jagotec AG, Jago
Holding AG, Jago Pharma AG and Genta Jago Technologies
B.V.
10.50(7)(12) Limited Liability Company Agreement of Genta Jago Delaware
LLC dated as of May 12, 1995 between GPM Generic
Pharmaceuticals Manufacturing Inc. and the Company.
10.51(7)(12) Restated Transfer Restriction Agreement dated as of May
12, 1995 between the Company and Jagotec AG.
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<PAGE>
10.52(7)(12) Transfer Restriction Agreement dated as of May 12, 1995
between the Company, GPM Generic Pharmaceuticals
Manufacturing Inc. and Jago Holding AG.
10.53(7)(12) Common Stock Transfer Agreement dated as of May 30, 1995
between the Company and Jago Finance Limited.
10.54(7)(12) Stockholders' Agreement dated as of May 30, 1995 between
the Company, Jagotec AG, Dr. Jacques Gonella and Jago
Finance Limited.
10.55(7)(12) Restated GEOMATRIX Research and Development Agreement
dated as of May 12, 1995 between Jago Pharma AG, the
Company, Genta Jago Delaware, L.L.C. and Genta Jago
Technologies B.V.
10.56(7)(12) Restated Services Agreement dated as of May 12, 1995
between Jago Pharma AG, the Company, Genta Jago Delaware,
L.L.C. and Genta Jago Technologies B.V.
10.57(7)(12) Restated Working Capital Agreement dated as of May 12,
1995 and Amendment No. 1 to Restated Working Capital
Agreement dated as of July 11, 1995 between the Company
and Genta Jago Technologies B.V.
10.58(7)(12) Restated Promissory Note dated as of January 1, 1994
between Genta Jago Technologies B.V. and the Company.
10.59(7)(12) Restated License Agreement dated as of May 12, 1995
between Jagotec AG and the Company.
10.61(7)(12) Restated GEOMATRIX License Agreement dated as of May 12,
1995 between Jagotec AG and Genta Jago Technologies B.V.
10.62(7)(12) GEOMATRIX Manufacturing License Agreement dated as of May
12, 1995 between Jagotec AG and Genta Jago Technologies
B.V.
10.63(7)(12) Restated GEOMATRIX Supply Agreement dated as of May 12,
1995 between Jago Pharma AG and Genta Jago Technologies
B.V.
10.65(13) Form of Regulation S Subscription Agreement entered into
between the Company and certain purchasers of the Series B
Convertible Preferred Stock.
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<PAGE>
10.66(1) Promissory Note dated November 8, 1995 between the Company
and Domain Partners, L.P.
10.67(1) Promissory Note dated November 8, 1995 between the Company
and Domain Partners II, L.P.
10.68(1) Promissory Note dated November 8, 1995 between the Company
and Institutional Venture Partners, IV.
10.69(14) Amendment to Promissory Note effective March 22, 1996
between the Company and Institutional Venture Partners,
IV.
10.70(14) Amendment to Promissory Note effective March 22, 1996
between the Company and Domain Partners, L.P.
10.71(14) Amendment to Promissory Note effective March 22, 1996
between the Company and Domain Partners II, L.P.
10.72(15) Amendments to the Series C Securities Subscription
Agreement dated April 23, 1996.
10.73(16) Form of Regulation S Securities Subscription Agreement
entered into between the Company and certain purchasers of
the 4% Convertible Debentures, Due August 1, 1997.
10.74(16) Form of 4% Convertible Debenture Due August 1, 1997.
10.75(19) Note and Warrant Purchase Agreement dated as of January
28, 1997, by and among the Company, The Aries Fund, A
Cayman Island Trust (the "Trust") and The Aries Domestic
Fund, L.P. (the "Partnership").
10.76(19) Letter dated January 28, 1997 from Genta Incorporated.
10.77(19) Senior Secured Convertible Bridge Note of the Company
dated January 28, 1997 for $1,050,000.
10.78(19) Senior Secured Convertible Bridge Note of the Company
dated January 28, 1997 for $1,950,000.
10.79(19) Class A Bridge Warrant of the Company for the purchase of
2,730,000 shares of Common Stock.
10.80(19) Class A Bridge Warrant of the Company for the purchase of
5,070,000 shares of Common Stock.
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<PAGE>
10.81(19) Class B Bridge Warrant of the Company for the purchase of
4,270,000 shares of Common Stock.
10.82(19) Class B Bridge Warrant of the Company for the purchase of
7,930,000 shares of Common Stock.
10.83(19) Security Agreement dated as of January 28, 1997 between
the Company and Paramount Capital, Inc.
10.84(19) Letter Agreement dated January 28, 1997 among the Company,
Paramount Capital, Inc., the Partnership and the Trust.
10.85(19) Amendment No. 1 dated as of January 28, 1997 to Rights
Agreement, dated as of December 16, 1997, between the
Company and ChaseMellon Shareholder Services L.L.C.
10.86(20)(6) Executive Compensation Agreement dated as of January 1,
1996 between the Company and Howard Sampson.
10.87(20) Collaboration Agreement dated December 26, 1995 between
the Company and Johnson & Johnson Consumer Products, Inc.
10.88(20) Assignment Agreement (of Gensia Inc.'s rights in the
Collaboration Agreement between Genta Jago and Gensia,
Inc., dated January 23, 1993) to Brightstone Pharma, Inc.,
dated October 1, 1996 among Gensia, Inc., Genta Jago
Technologies B.V., Brightstone Pharma, Inc., and
SkyePharma PLC.
10.89(20)(7) Development and Marketing Agreement effective February 28,
1996 between Genta Jago Technologies B.V., a Dutch
company, and Apothecon, Inc., a Delaware corporation.
10.90(20)(7) License Agreement effective February 28, 1996 between
Genta Jago Technologies B.V., a Dutch company, and
Apothecon, Inc., a Delaware corporation.
10.91(20)(7) Option, Development & Sub-License Agreement/(The Company
has requested confidential treatment for the name of this
element) dated as of October 31, 1996 between Genta Jago
Technologies B.V., a Dutch company, and Krypton Ltd., a
Gibraltar limited company.
10.92(20)(7) Development and Sub-License Agreement/(The Company has
requested confidential treatment for the name of this
element) dated as of October 31, 1996 between Genta Jago
Technologies
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<PAGE>
B.V., a Dutch company, and Krypton Ltd., a
Gibraltar limited company.
10.93(20)(7) Development and Sub-License Agreement/(The Company has
requested confidential treatment for the name of this
element) dated as of October 31, 1996 between Genta Jago
Technologies B.V., a Dutch company, and Krypton Ltd., a
Gibraltar limited company.
10.94(20)(7) Development and Sub-License Agreement/Diclofenac dated as
of October 31, 1996 between Genta Jago Technologies B.V.,
a Dutch company, and Krypton Ltd., a Gibraltar limited
company.
10.95(20)(7) Development and Sub-License Agreement/Naproxen dated as of
October 31, 1996 between Genta Jago Technologies B.V., a
Dutch company, and Krypton Ltd., a Gibraltar limited
company.
10.96(20)(7) Development and Sub-License Agreement/Verapamil dated as
of October 31, 1996 between Genta Jago Technologies B.V.,
a Dutch company, and Krypton Ltd., a Gibraltar limited
company.
10.97(20)(7) License Termination Agreement dated December 2, 1996
between the Company and Wilton Licensing AG.
10.98(20) Contract for Regional Aid for Innovation, effective July
1, 1993, between L'Agence Nationale de Valorisation de la
Recherche, Genta Pharmaceuticals Europe SA and the
Company.
10.99(22) Warrant for the purchase of 32,500 shares of Common Stock
of the Issuer, issued to the Aries Fund pursuant to a
Senior Secured Line of Credit Agreement between the
Company and the Aries Funds.
10.100(22) Warrant for the purchase of 17,500 shares of Common Stock
of the Issuer, issued to the Aries Domestic Fund, L.P.
pursuant to the Senior Secured Line of Credit Agreement
between the Company and the Aries Funds.
10.101(22) Amended and Restated Amendment Agreement between the
Company and the Aries Funds.
10.102(22) Amended and Restated Senior Secured Convertible Bridge
Note for $1,050,000 issued to the Aries Domestic Fund,
L.P.
10.103(22) Amended and Restated Senior Secured Convertible Bridge
Note for $1,950,000 issued to The Aries Fund.
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10.104(22) New Class A Bridge Warrant for the Purchase of 350,000
shares of Common Stock issued to The Aries Fund.
10.105(22) New Class A Bridge Warrant for the Purchase of 650,000
shares of Common Stock issued to The Aries Fund.
10.106(22) New Class B Bridge Warrant for the Purchase of 350,000
shares of Common Stock issued to The Aries Fund.
10.107(22) New Class B Bridge Warrant for the Purchase of 650,000
shares of Common Stock issued to The Aries Fund.
10.108(22) Consulting Agreement dated as of August 27, 1997 by and
between the Company and Paul O.P. Ts'o, Ph.D.
10.109(22) Consulting Agreement dated as of August 27, 1997 by and
between the Company and Sharon B. Webster, Ph.D.
22.1(20) Subsidiaries of the Registrant.
23.1(23) Consent of Ernst & Young LLP, Independent Auditors.
24.1 Power of Attorney (included on the signature page of the
Company's Annual Report on Form 10-K, filed on
April 15, 1998).
27.1(23) Financial Data Schedule
* Before giving effect to the one for ten reverse stock split effected by
the Company on April 7, 1997.
(1) Incorporated herein by reference to the exhibits of the same number to the
Company's Annual Report on Form 10-K for the year ended December 31, 1995,
Commission File No. 0-19635.
(2) Exhibit 3(ii).1 is incorporated herein by reference to the Exhibit of the
same number contained in Post-Effective Amendment No. 1 to the Company's
Registration Statement on Form S-3, Registration No. 33-72130.
(3) Exhibit 10.1 is incorporated herein by reference to Exhibit 10.1 to the
Company's Registration Statement on Form S-8, Registration No. 33-85887.
(4) Exhibits 4.2, 4.3, and 4.4 are incorporated by reference to Exhibits of
the same number to the Company's Report on Form 8-K dated as of September
24, 1993, Commission File No. 0-19635.
(5) Incorporated herein by reference to the exhibit of the same number to the
Company's Registration Statement on Form S-1, Registration No. 33-43642.
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(6) Indicates management contract, compensatory plan or arrangement.
(7) The Company has been granted confidential treatment of certain portions of
this exhibit.
(8) Exhibit 4.6 is incorporated by reference to Exhibit 10.65 to the Company's
Report on Form 8-K dated as of December 29, 1995, Commission File No.
0-19635.
(9) Incorporated by reference to the exhibits of the same number to the
Company's Registration Statement on Form S-3, Registration No. 33-58362.
(10) Incorporated by reference to the exhibits of the same number to the
Company's Quarterly Report on Form 10-Q for the quarter ended March 31,
1995, Commission File No. 0-19635.
(11) Incorporated by reference to Exhibit 5.1 to the Company's Report on Form
8-K dated as of December 16, 1993, Commission File No. 0-19635.
(12) Incorporated by reference to the exhibits of the same number to the
Company's Quarterly Report on Form 10-Q/A for the quarter ended June 30,
1995, Commission File No. 0-19635.
(13) Incorporated herein by reference to the exhibit of the same number to the
Company's Report on Form 8-K dated as of December 29, 1995.
(14) Incorporated herein by reference to exhibits 10.1, 10.2 and 10.3,
respectively, to the Company's Registration Statement on Form S-3
(Registration No. 333-3846)
(15) Incorporated herein by reference to Exhibit 10.1 to the Company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 1996,
Commission File No. 0-19635.
(16) Exhibits 10.73 and 10.74 are incorporated herein by reference to Exhibits
10.1 and 10.2 to the Company's Report on Form 8-K dated as of September
17, 1996, Commission File No. 0-19635.
(17) Exhibits 4.9 and 4.10 are incorporated herein by reference to Exhibits 4.1
and 4.2 respectively to the Company's Quarterly Report on Form 10-Q for
the quarter ended September 30, 1996, Commission File No. 0-19635.
(18) Exhibit 3(i).2 is incorporated by reference to Exhibit 3(i) to the
Company's Report on Form 8-K dated as of January 28, 1997, Commission File
No. 0-19635.
-114-
<PAGE>
(19) Exhibits 10.75, 10.76, 10.77, 10.78, 10.79, 10.80, 10.81, 10.82, 10.83,
10.84 and 10.85 are incorporated herein by reference to Exhibits 10.1,
10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 10.10 and 10.11
respectively to the Company's Report on Form 8-K dated as of January 28,
1997, Commission File No. 0-19635.
(20) Incorporated herein by reference to the exhibits of the same numbers to
the Company's Annual Report on Form 10-K for the year ended December 31,
1996, as amended, Commission File No. 0-19635.
(21) Exhibit 3(ii).2 is incorporated herein by reference to Exhibit 3(ii) to
the Company's Quarterly Report on Form 10-Q/A for the quarter ended
September 30, 1997, Commission File No. 0-19635.
(22) Incorporated herein by reference to the exhibits of the same numbers to
the Company's Annual Report on Form 10-K for the year ended December 31,
1997, Commission FIle No. 0-19635.
(23) Filed herewith.
(d) See (a)(2) above.
-115-
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, as amended, the Registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized, on this
16th day of April, 1998.
GENTA INCORPORATED
/s/Kenneth G. Kasses, Ph.D.
------------------------------------------
Kenneth G. Kasses, Ph.D.
President, Principal Executive Officer and
Director
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, this report has been signed below by Kenneth G. Kasses and Robert E.
Klem, in their respective individual capacities and by Kenneth G. Kasses on
behalf of the following persons, pursuant to the Power of Attorney constituting
Exhibit 24.1 hereto, in the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature(s) On behalf of Capacity Date
- ------------ ------------ -------- ----
<S> <C> <C> <C>
/s/Kenneth G. Kasses, Ph.D.
- --------------------------- Kenneth G. Kasses, Ph.D. President, Principal Executive April 16, 1998
Kenneth G. Kasses, Ph.D. Officer and Director
/s/Robert E. Klem
- -------------------------- Robert E. Klem, Ph.D. Principal Accounting Officer, April 16, 1998
Robert E. Klem, Ph.D. Principal Financial Officer,
Vice President and Director
/s/Kenneth G. Kasses, Ph.D.
- --------------------------- Glenn L. Cooper, M.D. Directors April 16, 1998
Kenneth G. Kasses, Ph.D. Donald G. Drapkin
Lawrence J. Kessel, M.D.
Peter Salomon, M.D.
Bobby W. Sandage, Jr., Ph.D.
Andrew J. Stein
Harlan J. Wakoff
Michael S. Weiss
</TABLE>
- 116 -
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration
Statements on Forms S-3 and S-8 of our reports dated April 13, 1998 and April
15, 1998 with respect to the consolidated financial statements of Genta
Incorporated included in the Genta Incorporated Annual Report on Form 10-K for
the year ended December 31, 1997 and Amendment No. 1 thereto, respectively
(collectively, the "Genta 1997 Annual Report") and our report dated April 13,
1998 with respect to the financial statements of Genta Jago Technologies B.V.,
included in the Genta 1997 Annual Report.
/s/ERNST & YOUNG LLP
-------------------------
ERNST & YOUNG LLP
San Diego, California
April 16, 1998
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED
FROM THE CONSOLIDATED BALANCE SHEETS AND CONSOLIDATED STATEMENTS
OF OPERATIONS CONTAINED IN THE COMPANY'S ANNUAL REPORT ON FORM
10-K/A FOR THE YEAR ENDED DECEMBER 31, 1996 AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 12-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> DEC-31-1997
<CASH> 1,202,668
<SECURITIES> 7,253,756
<RECEIVABLES> 431,046
<ALLOWANCES> 0
<INVENTORY> 826,008
<CURRENT-ASSETS> 9,931,991
<PP&E> 4,707,848
<DEPRECIATION> 2,989,698
<TOTAL-ASSETS> 15,753,903
<CURRENT-LIABILITIES> 5,369,071
<BONDS> 2,204,053
0
684
<COMMON> 5,712
<OTHER-SE> 9,418,602
<TOTAL-LIABILITY-AND-EQUITY> 15,753,903
<SALES> 4,701,649
<TOTAL-REVENUES> 5,101,746
<CGS> 3,099,078
<TOTAL-COSTS> 16,561,402
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<INTEREST-EXPENSE> 227,160
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